Companies Aren’t Required To Respond To FDA 483s
A common question from drug and device manufacturers is how to respond to an FDA 483 or warning letter. Many employers think that the company has to respond to the FDA citation within 15 days, but this isn’t true, according to Gina Brackett, who is the director of compliance at the Office of Medical Device […]
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Eugia Hit With Another 483 in Less Than a Year
Sterile drug manufacturing company Eugia stays under major FDA scrutiny, as the division of Aurobindo has been hit with its fifth FDA 483 since the end of 2023. The firm’s latest criticism from FDA is related to an April and May cGMP audit. The sterile drug manufacturer received seven agency observations. Most of the 483 […]
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Dr. Reddy’s Laboratories Slapped With 483 After FDA Preapproval Inspection
Dr. Reddy’s Laboratories has been hit with another 483 for problems with its production facilities. FDA performed a preapproval inspection at the firm’s formulations manufacturing plant which is known as FTO 11. Dr. Reddy’s told the press that the agency gave them a two-item 483 that focused on subpar manufacturing standards. The FDA inspection took […]
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FDA Commissioner Wants To Revamp The Evidence Generation System
FDA Commissioner Rob Califf said last week that he wants to combat scientific misinformation and create new ways to increase the use of the evidence generation system that FDA relies on to make its drug approval decisions. Califf referred to the agency as a decision-making machine and an organization that is ‘a referee that plays […]
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FDA User Fee Bill Deadline Passes; FDA Reviewers May Be Laid Off
The fight over what should be included in the latest round of FDA user fee legislation – the money from the pharma industry that pays for drug and biologic reviews at the agency that must be reauthorized every five years – is reaching a climax this month. Congress is attempting to meet a recess deadline […]
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EMA Planning Transition To Reviewing Raw Clinical Data
FDA often talks about the fact that it’s the only global pharma regulator that reviews raw clinical data, meaning the data of individual patients during its pharmaceutical application reviews. This often allows FDA to avoid what could be misleading or biased data offered by a drug sponsor. This month, the European Medicines Agency (EMA) is […]
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Texas Pharmaceutical Company Hit With 483 For Missing Records and Inadequate Processes
A Texas drug manufacturer received a 483 on June 10, 2022 for missing records, inadequate processes and inappropriate controls as well as other CGMP violations. The company is Monarch PCM and it’s based in Fort Worth. The facility manufactures tablets, liquids, lotions and creams, and was audited by FDA between June and August 2021. The […]
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Congress Urges FDA To Adopt Clearer, Neutral Rules For Pharmaceutical Drug Ads
Several members of the US House, including Katie Porter, who often interrogates pharmaceutical executives on The Hill, wants to force FDA to adopt a proposal from 2010 about some of the distractions that are in direct-to-consumer drug advertisements. The long-delayed proposal would come up with standards that would ensure that pharmaceutical drug risks and important […]
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FDA Notes cGMP Failures In Warning Letter For 503B Compound Outsourcing Facility
After it stopped sending FDA warning letters to 503B outsourcing facilities in 2021, FDA gave a warning letter in June 2022 to Hybrid Pharma after an FDA inspection that concluded in late 2021. It looks like FDA is returning aggressively to the 483 and warning letter trend, as the same pharmaceutical company got another warning […]
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Aurobindo Pharma Hit With Warning Letter From Indian SEC After More FDA Questions
Generic drug manufacturer Aurobindo Pharma based in India has been under the gun from FDA for years, but now the company is getting unwanted attention from Indian regulators. The website Business Standard in India reported last month that the company was sent a warning letter from the Security Exchange Board of India (SEBI). The warning […]
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