Tag Archives: 483 response

FDA Warning Letter on AI-Generated cGMP Records: What It Means

FDA Issues First Warning Letter Addressing AI-Generated Drug Specifications and Master Production Records FDA issues a Warning Letter addressing “the use of AI in creating the drug product specifications, procedures, and master production or control records” The FDA recently issued a warning letter to a US pharma company that had many FDA cGMP issues. This is the first time we have seen

How to Respond to an FDA 483 and Warning Letter – Precautionary Measures

The FDA themselves state it is industry’s responsibility to work with investigators before they leave the company to remove all incorrect points on the 483. The FDA is also supposed to annotate the 483 concerning your corrective actions that were accomplished during the inspection. From latest experience with the new FDA investigators, this advice doesn’t

How to Respond to an FDA 483

FDA Inspections & Compliance How to Respond to an FDA 483 — and Prevent a Warning Letter A company that receives a Form 483 has one opportunity to demonstrate control, credibility, and corrective action before the FDA decides whether to escalate. This guide — written by a former FDA field investigator — shows exactly how

FDA Launches One-Day Inspectional Assessments to Strengthen and Expand Oversight

FDA Update PLEASE BE AWARE THAT THE FDA HAS LAUNCHED THE FOLLOWING PROGRAM. WHAT DOES IT MEAN TO YOU? FDA Launches One-Day Inspectional Assessments to Strengthen and Expand Oversight The U.S. Food and Drug Administration today announced that it is piloting one-day inspectional assessments, as part of a broader initiative to make its inspectional resources

BD receives FDA warning letter

FDA Update BD receives FDA warning letter over quality system violations Becton Dickinson (BD) has received a warning letter from the FDA regarding quality system violations at a facility that manufactures its Pyxis medication management system. The FDA identified several concerns, including: Failure to adequately investigate complaints: The FDA found over 92,000 complaints related to

FDA update: Warning – The FDA Restarts Routine Domestic Surveillance Inspections

FDA Update February 10, 2022 Warning – FDA could be knocking on your door! The FDA Restarts Routine Domestic Surveillance Inspections With the decline of Covid-19 cases across the country, the FDA has decided to re-start their routine domestic surveillance inspections in the US. The FDA will also resume their foreign surveillance inspections provided that

FDA Inspections in China with 5 day notice

BEWARE – FDA Inspections in China with 5 day notice mdi recently received an email from one of our clients in China that read: “We just received a “notice” from the USA FDA via the US Embassy in Beijing that there will be an inspection this coming Monday. Is this normal to be contacted from