Here’s 10 recent stories that have hit our radar related to FDA 483s:
- FDA GMP inspectors cite 70% of dietary supplement firms within 3 years. Frankly, I’m surprised that it wasn’t closer to 90%. Average number of FDA 483 observations – 7.
- Impax hires 3 gurus to fix their manufacturing woes. A little unusual, but they actually do some name-dropping on who they brought in. (see the insider perspective in the comments)
- FDA hits Boehringer-Ingelheim with warning letter. This is after they failed to respond adequately from a previous FDA 483, where finding the source of “foreign particles” into the system was still a mystery. Said the FDA, “Quality can’t be added into the product after its been manufactured.” Ouch.
- Another warning letter for Hospira. Double ouch. (see the insider perspective in the comments)
- FDA (and Congress?) stepping up with inspecting compounding facilities. One congressman said, “Ten years of warning signs, alarm bells and flashing red lights were deliberately ignored.” From February to April 2013, the FDA sent inspectors to 31 compounding facilities and have posted the 483s.
- Can cGMP issues actually hamper clinical filings/approvals? This law firm thinks so and gives us a real case study: Gilead. If this is true, then cGMP inspections just got at least 10x more important. (Update/correction* below)
- It’s confirmed. FDA citations of Medical device quality systems have been steadily increasing over 4 years. Emergo group shares the hard data.
- New YouTube video presentation on FDA 483s, from a consulting firm Compliance Insights.
- 3 Food companies get slapped with FDA warning letters. The FDA even said that one of the companies has a history of “promising” correction action after a FDA 483, but not actually taking any real action.
- What if your 483 response was released to the public? That’s what happened to Alexion. In all its 22-page glory.
What FDA 483 stories have hit your radar this month?
- FDA 483s store – instant, anonymous access to 483 PDFs
- Free, searchable list of 5 years of 483s
- The FDA conducted 40,000 inspections in 2012
*UPDATE/CLARIFICATION: #6 above references an article by a reputable law firm that tied “manufacturing deficiencies” with these clinical filings. When I dug deeper into the source documents, I found that the 483 was not cGMP related, but related to lab/testing procedures (still considered “manufacturing” by FDA definitions).
The 483 that was issued noted deficiencies in test methods, specification of instruments used, laboratory records, control and test procedures, stability testing, and laboratory controllers. Source: Yahoo Finance
In the last few days, the FDA told Gilead Sciences ($GILD) it needed to fix quality testing issues before it would consider approving a pair of new drug applications. Source: Fierce Pharma Manufacturing