FDA cGMP Compliance News and Tips by Expertbriefings.com

January 3rd, 2014 // 5:14 am @ jmpickett

Below are the original Expertbriefings.com cGMP and FDA-related stories for 2014. Be sure to review our new FDA Digest e-newsletter – learn FDA news and compliance tips, and also read our exclusive 483 and warning letter reports.

FDA cGMP Compliance News and Tips

March 4 – Will OTC Lipitor Win FDA Approval?
Feb. 26 – FDA Overhauls Drug Approval Path for OTC Drugs
Feb. 19 – FDA Chief Says Indian Drugmakers Must Improve cGMP Quality
Feb. 13 – FDA Is Refusing to Allow Ranbaxy Labs to Export from Banned Factories
Feb. 10 – FDA Seeks More Information on Female Libodo Drug
Feb. 10 – How Effective Are FDA Approvals?
Feb. 3 – FDA Investigating Risks of Testosterone Therapy
Jan. 30 – FDA Says Aleve Is Safer for Heart Than Other NSAIDs
Jan. 23 – Evidence Quality That FDA Uses to Approve Drugs Varies Widely
Jan. 20 – Remove a Wart, Burn Down Your House?
Jan. 20 – MRC Tells Congress – Do Not Pass Legislation – Wait for FDASIA Report
Jan. 15 – FDA Warns That Acetaminophen Dosages Over 325 MG Can Cause Liver Damage
Jan. 10 – FDA: OTC Laxatives Can Kill
Jan. 8 – eTMF Use Still Not Nearly As High As It Could Be
Jan. 7 – How Dangerous Are E-Cigarettes?
Jan 6 – Wanted by FDA – Gum Chewing Tester
Jan. 6 – Company in VA Governor’s Supplement Scandal Receives FDA Warning
Dec. 14 – FDA Approves 1st Device to Combat Migraine Headaches
Dec. 14 – FDA Cracking Down on Anti-Bacterial Soaps
Dec. 11 – FDA Sends Harsh Warning Letter to Houston Cancer Doctor
Dec. 9 – 23andMe Still Optimistic Despite FDA Warning
Dec. 9 – GSK Research Based on China Data Is Retracted
Dec. 5 – 23andMe to Stop Test Sales After FDA Order
Dec. 4 – Major Job Cuts at Merck in Ireland, Forest Labs, Eisai
Dec. 2 – Main Wockhardt Drug Plant in India Banned by FDA
Nov. 24 – DNA Test Maker Hit with Nasty FDA Warning Letter
Nov. 21 – HHS OPDP Warning Letter Rips Kadmon Pharma
Nov. 21 – Layoffs Continue in Pharma in November
Nov. 20 – J&J To Pay $2.5 Billion to Settle Hip Replacement Lawsuit
Nov. 18 – Merck Ends API Production in Plant in Puerto Rico
Nov. 15 – Chicago Government Issues Subpoena to J&J in Investigation
Nov. 14 – House of Representatives to Grill FDA on FDASIA
Nov. 13 – Another Nasty 483 for Hospira
Nov. 13 – What You Must Know About New Cholesterol Guidelines
Nov. 7 – Shire Cutting More UK R&D Jobs – CEO Overhauls Operations
Nov. 6 – FDA Trying to Increase Placement of Auditors in China
Nov. 5 – J&J Pays $2.2 Billion to End FDA Drug Probes
Nov. 5 – FDA Looking Into Advertising of ADHD and Acne Drugs in Teens
Nov. 4 – GSK Execs Facing Bribery Charges in China
Oct. 30 – New Study Casts Doubt on FDA Shorter Drug Approval Time
Oct. 30 – Vertex to Chop Over 300 Jobs, and Pay Back MA Tax Credits
Oct. 28 – FDA Recommends More Restrictions on Some Painkillers
Oct. 25 – Interesting Hire – Simcere Hires Scandal-Plagued GSK R&D Exec
Oct. 25 – Researcher at Bristol Myers Faked Data in Grants and Doctoral Thesis
Oct. 24 – Agila Hit With Serious 483 and Warning Letter – Holes in Gloves?
Oct. 16 – Government Shutdown Affecting FDA Drug Approvals
Oct. 16 – FDA Issues Recall for B. Braun Medical Antibiotic
Oct. 16 – FDA Acting at Lower Capacity During Shutdown, But User Fees Helping
Oct. 15 – Is FDA Going to Recommend the Amarin Fish Oil Pill?
Oct. 14 – UK’s MHRA Blasts Wockhardt Plant for cGMP Problems
Oct. 10 – Who Will Succeed Janet Woodcock at FDA?
Oct. 10 – FDA Favoring DUNS for Manufacturing Plant IDs in FDASIA
Oct. 9 – Surprise FDA Visits Rising in India
Oct. 9 – Lilly Employee Disaster – Charged With Stealing R&D Secrets
Oct. 8 – Should Pharma Company Pay Punitive Damages?
Oct. 7 – J&J Must Warn Consumers About Ties Between Talcum Powder and Ovarian Cancer
Oct. 7 – Boehringer Ingelheim Shuts Down Ben Venue Forever
Sept. 27 – Pharmaceutical Shortages Persisting as Manufacturing Problems Continue
Sept. 27 – Japan Plans to Invade Novartis Offices for Diovan Scandal
Sept. 26 – Burzynski Research Institute IRB Fails Another FDA Audit
Sept. 26 – With FDASIA, FDA Increases Inspections of Indian Drug Facilities
Sept. 23 – Indian Drugmaker USV Slammed with FDA 483
Sept. 23 – Do Cholesterol Lowering Drugs Cause Cataracts?
Sept. 19 – Drug Repackager Slammed With Consent Decree for Mislabeling
Sept. 19 – What Did in Ranbaxy – Hair, Oil Spots and Bathrooms Without Water
Sept. 18 – Ranbaxy Labs Import Alert DisasterÂ – Caused by Arm Hair?
Sept. 18 – Celltrion Shocked by Insider Trading Charges
Sept. 18 – Chinagate Scandal Now Implicating Alcon
Sept. 16 – Oops, They’re in Trouble Again – Ranbaxy Labs Import Alert
Sept. 16 – Pfizer Screw Up Leads to Nerve Gas Antidote Shortage
Sept. 13 – Prescription Fish Oil Pill Stink
Sept. 12 – Ensuring that Ingredient Supplier Audits Are Free of Bias
Sept. 12 – Major R&D Changes Planned at Merck
Sept. 11 – 5 Critical Tips to Solve an FDA Warning Letter Crisis
Sept. 10 – FDA Announces New Warnings on Opioid Painkillers
Sept. 10 – Reminders About FDA Requirements for Qualifying Vendors
Sept. 10 – Three Simple FDA CAPA Tips to Ensure Compliance
Sept. 9 – No Need to Validate the Software in Design and Development? Wrong!
Sept. 9 – Most Common FDA 483 Violations for Medical Devices
Sept. 5 – New FDA Warning Letters Point Out CAPA Flaws
Sept. 5 – FDA cGMP Inspections Getting More Intense in US
Sept. 3 – Latest Trends in cGMP Compliance
Sept. 3 – GSK Bribery in China Coordinated at High Level?
Aug. 30 – 6 Tips to Avoid 510(k) Submission Delays
Aug. 29 – Two More India API Companies Earn FDA Warning Letters
Aug. 29 – FDA Warnings Going Social
Aug. 28 – Tips and Thoughts on Critical Process Cleaning Procedures
Aug. 28 – FDA – 70% of Dietary Supplement Companies Violate cGMPs
Aug. 27 – Warning Letter Trend Suggests Crackdown on Contract Manufacturing, Using Park Doctrine
Aug. 27 – Lonza Cutting Jobs at Massachusetts Plant by End of 2013
Aug. 26 – Fresenius Slammed With Warning Letter for Complaint Handling
Aug. 26 – No Device Complaints – No Problems? Think Again
Aug. 22 – Tips to Qualify Your Pharmaceutical Ingredient Suppliers
Aug. 22 – Scandal Widens: Ex Lilly Manager Says Docs Paid $5 Million
Aug. 22 – Top 10 Reasons Deviation Investigation Systems Fail
Aug. 20- Is Troubled J&J Tylenol Plant Ready to Reopen?
Aug. 20 – FDA Inspections Held Up by Visa Delays in China
Aug. 19 – Should a Prostate Drug Be Used to Stop Cancer?
Aug. 19 – Boehringer Ingelheim Closes WV Plant, Cutting 240 Jobs
Aug. 15 – FDA Looks Closely at Opioid APIs
Aug. 15 – Could FDA Have Stopped the Bacterial Infections Traced to NECC?
Aug. 14 – FDA Approves Two New, Promising HIV Drugs
Aug. 14- China Bribery Scandal Now Engulfs Novartis
Aug. 13 – Source: West Ward Pharmaceutical Giving Bonuses Only to Non-Union Workers?
Aug. 13 – Acorda Therapeutics Slammed With New Warning Letter for Ads
Aug. 7 – DCGI in India to Review cGMP Compliance for Ranbaxy Facilities
Aug. 7 – FDA Orders Acetaminophen Warning
Aug. 6 – Serious Novartis Scandal Causes Japan to Mull Penalties for False Data
Aug. 6 – TV Ads for Statins Cause Overdiagnosis and Prescribing
Aug. 5 – FDA Blasts Cispharma in Warning Letter for Poor Inury Investigation
Aug. 5 -Â AMRI Hit With Another 483 in Burlington MA
Aug. 2 – Valeant CEO Ripped by New York Politicians for Moving HQ
July 31 – Lower Irish Tax Rate Closes Perrigo/Elan Deal
July 31 – Valeant Chops 2850 Workers After Recent Bausch and Lomb Deal
July 31 – McKesson Plans to Fight Clawback Policy
July 29 – EMA Says No Pancreatic Cancer Risk With Diabetes Drugs
JulyÂ 29 – Chinese Authorities Release More Sordid Glaxo Scandal Details
July 26 – Glaxo Telling Muddled Stories on Chinese Bribery Trainwreck
July 26 – IMS Health Accused of Eliminating Competition to Gain Monopoly
July 25 – PhRMA Ranked as Top Lobbying Group in DC
July 24 – The Glaxo China Trainwreck – Bribes, Hidden Study Results and More
July 24 – Urine Puddles and Destroyed Records – FDA Hits Wockhardt Hard in Latest Warning Letter
July 23 – Mallinckrodt Shells Out $3.5 Million to Settle Kickback Probe
July 23 – Damage Spreads for Glaxo in China Bribery Scandal – Execs Oversaw Bribes
July 22 – Eli Lilly Enacts Pay Raise Freeze for Employees
July 22 – Wockhardt Plant in India Gets FDA Warning Letter
July 19 – Bristol Myers Squibb Adding 579 Jobs in Tampa, Florida
July 19 – Glaxo Execs Forced to Stay in China Over Bribe Accusations
July 18 – Feds Suspect Novartis of Shady Marketing of Gilenya MS Pill
July 17 – J&J Pays $23 Million to End Recall Lawsuit
July 17 – FDA Issues Guidance on How to Avoid Inspection Problems
July 17 – FDA Sends Warning Letter to Genentech Trial Investigator
July 16 – Fraud Charge on Danish Doc for Payments from Drugmakers
July 16 – 5 Ways to Avoid cGMP Problems with FDA
July 15 – GSK Now the Leader in Chinese Bribery Scandal
July 15 – Fake Avastin Salesman Ducks Jail Time
July 12 – Lawyer Fights with FDA on J&J Risperdal Court Papers
July 12 – China Arrests Dozens of Glaxo Employees in Epic Scandal
July 11 – Hikma Hit With Warning Letter, Closes West Ward Plant for Fixes
July 11 – GSK Executives in China Admit to Bribery, Tax Crimes
July 10 – Frensenius API Plant Gets FDA Warning Letter
July 10 – Europe Devises Water Pollution Watch List for Drugs
July 10 – MHRA Bans Wockhardt from Making Drugs for European Market
July 9 – FDA Planning Big Changes to Generic Warning Labels
July 9 – Merck Gets Big Preemption Win
July 8 – GSK Investigates Illegal Sales Practices for Botox
July 8 – Ranbaxy Plans to Chop Hundreds of Jobs
July 5 – FDA Sends Nasty Warning Letter to Honey Company
July 5 – SEC Charges Insider Trading at Onyx Pharmaceuticals
July 3 – Ranbaxy Drugs Are Declared Safe in Australia
July 3 – Where is Big Pharma Hiring These Days?
July 2 – FDA Inspections Set to Spike in India
July 2 – FDA Rejects New Merck Sleeping Pill – For Time Being
July 1 – Writing Effective SOPs for Pharma
July 1 – Glaxo Employees Held in China on Graft Probe
June 28 – Ensuring Effective SOPs in the Pharmaceutical Industry
June 28 – FDA Drops the Hammer – 1677 Online Pharmacies Closed
June 27 – Medical Device CEO Held Hostage in China
June 26 – Intuitive Surgical Blasted in 483 for Not Reporting Warning
June 26 – India Cancels J&J Plant License
June 26 – DTC Drug Ad Text Is Too Hard to Read, Group Says
June 25 – Ranbaxy Slammed With Another Nasty 483
June 25 – Indian Court Tosses Criminal Suit for Ranbaxy Labs
June 24 – FDA Cracking Down Harder on Indian cGMP Problems
June 24 – Maine Legislature Votes to Allow Drug Imports from Foreign Pharmacies
June 21 – Cephalon Reps Shown Trays of Cash to Promote Off Label Use
June 21 – AMA Fights Fat and Boosts Pharma With Obesity Decision
June 20 – China Blasts J&J Over Product Recalls
June 20 – Eli Lilly Fighting Scam Artists Over Illegal Name Use
June 19 – USSC Says that Pharma Companies Can Be Sued for Pay to Delay Deals
June 19 – FDA Probes Deaths of Zyprexa Patients
June 18 – FDA Inspectors Find Mess During Audit of TN Pharmacy
June 18 – Japan Terminates Recommendations for HPV Vaccines
June 17 – FDA Issues Medical Device Alert Over Malware
June 17 – FDA Zeroes in on Patient-Focused Drug Development
June 17 – Major Operations Overhaul at Merck by New R&D Exec
June 14 – New Warning Letter Shows FDA Moving Beyond Basic cGMP Issues
June 14 – Major Insurer Stops Coverage for Compounded Drugs
June 13 – Download Free FDA Digest Sample Newsletter Today!
June 13 – Why Are Most Americans Ducking Clinical Trials?
June 13 – Pfizer and Teva Reach $2 Billion Deal on Patent Spat
June 13 – More Glaxo Scandals in China – Bribing Doctors to Prescribe Meds
June 12 – Glaxo Fires Exec For Faked Data in Scientific Paper
June 12 – Walgreens Pays $80 Million for Controlled Substances Act Violations
June 11 – Baxter Healthcare Receives Especially Nasty Warning Letter
June 11 – GSK HQ Is a 10×10 Foot Office in….Delaware
June 11 – Ex-Bristol Myers Exec Pleads Guilty to Insider Trading
June 7 – Past Expertbriefings.com Webinars – Download Today!
June 7 – When a Medical Device Company Crosses the Line Into Crime
June 7 – Bear Bile Drugs in China Cause Outcry
June 7 – FDA Panel Votes to Ease Up Avandia Restrictions
June 6 – FDA Ordered to Make Plan B Pills Available
June 6 – GSK Probes Allegedly Fake Clinical Trial Data Produced by Employees
June 5 – Should FDA Be Holding the Avandia Advisory Committee Meeting?
June 5 – Novartis Manufacturing Plant Slammed With Warning Letter
June 4 – J&J Recall Nightmare – 32 Million Boxes of Contraceptives in 43 Countries
June 4 – What Should FDA Do About Ibuprofen?
June 3 – FDA Scientists Do Not Find Misconduct in Avandia Trial Data
June 3- Lundbeck Slapped with Big Fine in EU for Pay to Delay Deals
June 3 – How Well Do Drugmakers Understand Informed Consent?
May 31 – Hospira Keeps Getting Warning Letters – Is a Consent Decree Coming?
May 31 – Rogue FDA Reviewer Insists that ARB Heart Drugs Cause Cancer
May 30 – Major cGMP Problems Lead to Drug Shortages
May 30 – AbbVie Chops 100 Scientist Jobs
May 30 – Age Discrimination Accusations at Shire
May 29 – FDA Releases Draft Guidance on Contract Manufacturing
May 29 – New Compounding Pharmacy Scandal in TN
May 29 – Greed and Post-Marketing Requirements Lead to Trouble for Shionogi
May 28 – Forest Lab CEO Retires, But Feds Issue Subpoena
May 28 – Tips to Vacuum Your Cleanroom
May 28 – Ranbaxy Ignored Consultant Warnings About Major cGMP Problems
May 27 – FDA Data Reveals More Warning Letters to Medical Device Companies
May 27 – FDA Slams Boehringer-Ingelheim with Warning Letter
May 27 – Impax Brings In Specialists to Fix cGMP Problems
May 24 – Ranbaxy Labs Blasts Salvo at Daiichi Sankyo
May 24 – Novartis Admits It Did Wrong in Diovan Trials
May 23 – Hidden FDA Agenda for Avandia Meeting?
May 23 – J&J Tylenol Recall Disaster in Brazil
May 23 – Readying for a US FDA Inspection
May 22- FDA Inspectors Give 483s to 7 of 10 Dietary Supplement Companies
May 22 – How to Create and Staff Your FDA Inspection War Room
May 22 – Major Shake Up at Boehringer After Warning Letter Disaster
May 21 – J&J Soul Searching – Help Us With Our Credo
May 21 – FDA Set to Regulate Fecal Transplants
May 21 – Actavis Departs to Ireland for Lower Taxes
May 20 – Bristol Myers Hit With Fine for Monkey Deaths
May 20 – Pharmaceutical Cargo Thefts on the Rise
May 20 – Another Risperdal Lawsuit Slams J&J
May 20 – Serious Drug Recalls on the Rise
May 16 – FDA Slams Hospira With Another Warning Letter
May 16 – Court Tells FDA That FSMA Deadlines Are Required
May 16 – How Ranbaxy Tried to Screw FDA
May 16 – Criminal Charges on J&J in South Korea Tylenol Case
May 15 – How to Improve Your CAPA System
May 15 – Watch Out for What You ‘Like’ – FDA Is Watching Your Facebook Page
May 15 – Recent FDA Warning Letter Lessons Show FDA Is Watching Facebook
May 15 – More Pharma Jobs Get the Axe
May 14 – How to Keep Up With Medical Device Demand and Keep Quality High
May 14 – Ranbaxy Production Scandal Costs $500 Million
May 14 – Why Did Senior FDA Official Leave Agency? Congressional Probe Begins
May 13 – New FDA Warning Letter Shows Web Content Is Extension of Labeling
May 13 – Fired CRO Exec Says Firm Was Tracking Sexual Orientation of Hires
May 13 – 5 Screw Ups That Will Delay Your FDA 510(K) Approval
May 13 – Novartis Playing Catch Up on Vet Drug Production Woes At Nebraska Plant
May 13 – Essential Tips for New FDA 510(K) Refuse to Accept Policy
May 8 – Bayer Warned – Pull False Vitamin Claim or We’ll Sue
May 8 – Eli Lilly Chops Hundreds More Sales Rep Jobs
May 8 – More J&J Uproar: Employees Sue for Age Discrimination
May 7 – Update – Tanning Bed Ban for Teens Not Off the Table, FDA Warns
May 7 – FDA Plans to Reclassify Tanning Beds as Class II Medical Devices
May 7 – Is Selling Viagra Direct Online a Good Idea?
May 7 – Teva Regrets Canning Worker With Brain Tumor
May 6 – Absolute Worst FDA Warning Letter Responses
May 6 – FDA Ponders – Is Tricolsan Safe?
May 6 – J&J Stops Tylenol Production in South Korea
May 6 – Caffeinated Gun Causes New FDA Investigation
May 3 – Scandal Over Conflict of Interest for Novartis Trial
May 3 – Essential Tips for Bulletproof cGMP Quality Agreements
May 2 – Why So Few FDA Warning Letters?
May 2 – Did Judge Go Too Far on Plan B Pill?
May 2 – Novartis Dumps OTC Drugs Produced at 483-Plagued NE Plant
May 2- FDA Wants Help on Think Tank for Opioid Trials
May 2 – Got MS? Have a Free Lunch on Novartis
May 1 – Raised Eyebrow Alert – High Level FDAer Leaving for Mylan
May 1 – FDA Deputy Commissioner Moves on to Mylan
May 1 – FDA Releases Ugly Novartis 483 for Lincoln NE Plant
April 30 – FDA Allows Access to Plan B for 15 Year Olds
April 30 – Give Attention to Equipment Calibration Certificates
April 30 – Free FDA Compliance and cGMP Reports
April 30 – 5 Tips for Rock Solid Supplier Controls
April 30 – FDA and Allergan Warn About Fake Botox from Overseas
April 30 – More Counterfeit Drugs Pop Up – What to Do?
April 29 – How to Optimize Your Quality System to Ensure FDA and ISO Compliance
April 29 – 3 More Tips for Excellent cGMP Plant Design
April 29 – The Clock Is Ticking Part 2 – 15 Days to Respond to 483
April 29 – Hooters and Fishing Trips for Docs – Has Novartis Violated Corporate Integrity Agreement?
April 29 – Senate Bill Gains Major Support to Boost FDA Muscle on Drug Compounders
April 25 – The Clock is Ticking – Responding to FDA 483 in 15 Days
April 25 – FDA Raids Cancer Clinic, Confiscates Laetrile
April 25 – Salesman for Fake Avastin Pleads Guilty to Felony
April 25 – FDA Counterfeit Device Detector Targets Fake Malaria Drugs
April 25 – Monkey Abuse Scandal – Harvard Shutting Down Primate Research Center
April 24 – Effective Project Management for Developing Medical Devices
April 24 – GMP Problems Result in 300 Jobs Chopped at Novartis Plant
April 24 – More Evidence of Link Between Autism and Antidepressants
April 24 – Novartis Sued by Federal Government for Massive Kickback Scheme
April 23 – FDA Mulls Petition to Protect Patents for Biologic Medications
April 23 – FDA Recognizes OxyContin Abuse with New Reformulation
April 23 – Congress Preparing Legislation to Improve Pharmaceutical Supply Chain
April 23 – FDA Blasts Teva for Overblown Marketing Materials
April 22 – 3 Best Practices for Strong cGMP Plant Design
April 22 – More Drug Compounding Recalls for Bacteria in Vials of Sterile Product
April 22 – FDA Wants More Regulatory Authority to Regulate Drug Compounding
April 22 – Aptuit Employee Busted and Jailed for Clinical Trial Data Scams
April 22 – Essential cGMP Quality Tips for Senior Managers
April 19 – The Risks of an FDA Import Alert
April 19 – FDA Opts for Public Safety Over Pain Med Access
April 18 – 5 Lab Calibration Tips – Stay Ahead of the cGMP FDA Inspector
April 18 – Contract Manufacturing Organization Hit with cGMP Warning Letter
April 18 – Revision of Clinical Trial Ethics in Helsinki Declaration
April 18 – FDA Guidance on Quality Agreements for CMOs Much Needed
April 17 – 5 Crucial Tips to Deal With an FDA Warning Letter
April 17 – Perfect OOS Results Will Make FDA Auditor Nervous, and Other cGMP Inspection Issues
April 17 – And the #1 cGMP 483 Observation for 2012 Is…
April 16 – cGMP Consultant Paid $1000 a Day for Assembling Binders?
April 16 – Why You Need a Strong Relationship with Your CMO
April 16 – Latest FDA cGMP Inspection Trends Highlighted at Recent Conference
April 15 – Stability Testing a Common Problem in FDA Warning Letters
April 15 – 21 CFR 211.194 – Tips for Laboratory Records cGMP Compliance for QC Labs
April 15 – 21 CFR 820.198- Implementing Risk-Based Management in Handling Complaints
April 13 – 21 CFR 820.198 – Avoiding Pitfalls in Your Complaint Handling Process
April 12 – Setting up Your Bulletproof MDR Files, and How to Avoid Landmines
April 12 – Understanding the Medical Device Reporting Regulations
April 10 – Expert Recommendations for FDA eCopy Submission
April 10 – Pfizer Hit with Warning Letter for Serious cGMP Manufacturing Problems
April 9 – Does My FDA eCopy Submission Meet FDA Requirements?
April 9 – eCTD Tips – Transitioning from Paper to Electronic Submissions
April 8 – Kabco Pharma Consent Decree Lesson – Provide Complete Warning Letter Reponse to FDA
April 8Â – How to Stay Compliant with 21 CFR Part 11
April 8 – You May Not Even Know You Are On Import Alert
April 8 – 15 Simple Steps for cGMP-Compliant Quality Systems
April 5 – How to Ensure FDA cGMP Compliance With Employees
April 4 – cGMP Inspection Tip – Best and Worst FDA 483 Response Letters
April 4 – The Urgent Danger of Repeat 483 Observations
April 3- Bugs and More Bugs – an FDA cGMP Inspection Disaster
April-3 FDA Not Really Hammering Pharma on Social Media, Report Finds
April 3 – 3 Tips to Handle Non-PDF Files in Your FDA eCopy Submission
April 2 – Bizarre – Cancer Research Compound Robbery
4 Tips for Pharma in Social Media From Former FDA Commissioner
More Clarity Needed on FDA eSource Trial Data Draft Guidance
Hospira Consent Decree Coming?
FDA/Customs Country of Origin Confusion on Drugs
cGMP Quality Agreement Tip – Remember Definitions!
Beg for a Warning Letter and FDA Says, “Sure!”
7 Tips to Hire a Top cGMP Consultant
Analysis: DEA Move Could Limit How Pharma Markets Heavy Painkillers
Stringent PDF Requirements A Roadblock for FDA eCopy
More Great FDA Inspection Tips (and One Unforgettable Quote from the FDA Compliance Director)
Is GSK Pressure on FDA Influencing Hospira 483 Failures?
Tips to Perform Your Next Laboratory Quality Audit
FDA Inspection Close Up – Using Strong Process Mapping and Gap Analysis
The Death of Paper – FDA eCopy
PDF Problems Reported with FDA’s New eCopy Rule
Former FDA Recall Chief – How to Design Your Recall Strategy
More Tips to Survive Your FDA Clinical Inspection
Danger! Legal Landmines in Your Company Records!
Using Effective Process Mapping, Gap Analysis and SOP Review
5 Do’s and Don’ts for Your Next FDA Inspection
Yes or No – Should You Shut Down Production During Your FDA Inspection?
Choppy Road Ahead for Confusing eCopy Initiative
Facebook Frisking Your FDA Auditor
Like Candy at Easter – FDA Hands Out CAPA 483 Observations
Industry Bafflement by CDRH eCopy Rule Continues; FDA Confused, as Well
Why Is CDRH’s eCopy Confusing Everybody?
Tip – Check Out Your Vendor Quality Before Signing the Deal
Why You Have to Have a Quality Agreement with Your Contractor
Avoid FDA – Move to Kansas 🙂
Avoid a CAPA File Inspection Disaster
How the Quality Manager Gets Fired aka the $100,000 FDA Compliance Mistake
Don’t Put Your Pharma Company in LA?
The Silent Treatment and Other Classic FDA Tricks
Top FDA 483 Citations – Recent Data, Plus More 806 Enforcement

FDA cGMP Compliance News and Tips by Expertbriefings.com

FDA cGMP Compliance News and Tips by Expertbriefings.com

FDA cGMP Compliance News and Tips

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