Anyone Can Enter Into a Quality Agreement, It’s the Hold: FDA Issues a Warning Letter Referencing Lack of Quality Oversight
Many of us remember the classic comedy bit on the Seinfeld television show where Jerry was unable to secure the rental car for which he had made a reservation. He tells the agent: See, you know how to ‘take’ the reservation, you just don’t know how to ‘hold’ the reservation and that’s really the most […]
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Federal Judge Issues Consent Decree for OTC Tennessee Drug Manufacturer
A federal court has issued an order to an over the counter drug company in Tennessee to cease the sale of OTC products until such time it is compliant with the FD&C Act. According to CDER, Americans both deserve and expect high quality OTC drug products. Although the company in question was given several warnings, […]
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Catalent Fixes 483 Citations at Bloomington, Indiana Plant
The US Food and Drug Administration (FDA) recently published a Form 483 it issued to Catalent’s biomanufacturing facility in Bloomington, Indiana following an inspection in April and May this year. The Agency made five observations at the 875,000ft2 production and fill/finish facility, which the contract development and manufacturing organization (CDMO) gained as part of its $950 million […]
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FDA Corrects Import Ban for Embattled Valsartan Maker
After Zhejiang Huahai Pharmaceutical’s tainted valsartan API triggered a global recall, the FDA slapped an import ban on the drugmaker. But the agency made a confusing mistake in announcing the move—a mistake it just corrected. The FDA announced Sept. 28 that it had imposed an import alert banning “all†active pharmaceutical ingredients made by Huahai, […]
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FDA Doubts McKesson’s Abilities to Detect Illegitimate Drug Products
The US Food and Drug Administration (FDA) recently posted a Form 483 sent in July to the nation’s largest drug distributor, McKesson, and questioned the firm on how it detects illegitimate products. The release of the Form 483 follows an investigation last year from the Washington Post and 60 Minutes highlighting McKesson’s failure to report suspicious orders involving millions of […]
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How to Fail an FDA Medical Device Inspection in 3 Easy Steps!
Have you ever thought about what the most common issues are in an FDA 483 for medical device manufacturers? The Medical Device Academy recently analyzed FDA 483s from 2013, and the research found that the most common observations were regarding design controls, CAPAs, and complaint handling. Design control problems were in 13.25% of all FDA […]
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What You Should Expect in GMP Quality Agreements
Have you wondered what the responsibility of your drug company is when it comes to the assurance of GMP quality and safety of products and ingredients that are made at your contract facility? It should be remembered that while the drug company has the ultimate responsibility for caregivers and patients to meet quality and safety expectations, […]
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Don’t Be Haunted By Your Words in Documents
Association of Food and Drug Officials Don’t Be Haunted By Your Words! By Nancy Singer and Joseph Pickett In this article, Ms. Singer and Mr. Pickett offer advice to both government and industry officials on writing clear and concise reports that won’t come back to haunt them in the future. How to Avoid Mistakes in […]
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DEA Moves Cannibidiol to Schedule V of the Controlled Substances Act
In a move that could eventually open the door to more FDA drug approvals for medicines that contain cannabidiol, the DEA last week, moved FDA-approved drugs with CBD to Schedule V of the Controlled Substances Act. The order puts drugs that have been approved by FDA and have no more than .1% of tetrahydrocannabinol or […]
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Tips for Implementing a Root Cause Failure Analysis Program
Implementing a root cause failure analysis program at a pharmaceutical facility can be challenging, especially when failures do not affect the quality of the product. Including failures that are not related to quality in your root cause failure analysis program can bring much value to a drug company. There are three major factors for your […]
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