Form FDA 483 Updates

10 FDA 483 News Stories

Here’s 10 recent stories that have hit our radar related to FDA 483s:

  1. 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.
  2. 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)
  3. 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.
  4. Another warning letter for Hospira. Double ouch. (see the insider perspective in the comments)
  5. 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.
  6. 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)
  7. It’s confirmed. FDA citations of Medical device quality systems have been steadily increasing over 4 years. Emergo group shares the hard data.
  8. New YouTube video presentation on FDA 483s, from a consulting firm Compliance Insights.
  9. 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.
  10. 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?

Other resources

*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

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2 thoughts on “10 FDA 483 News Stories

  1. Tony Chen Post author

    Got this from an industry insider today – great insights:

    #2. It’s very interesting to compare the 2012 and 2013 forms 483 issued to IMPAX. Seems they clearly didn’t get the message the first time, and it once again has held up approval of their innovator product and cost them $$$ as GSK cancelled their partnership on the product. Also, the inspection implicated a variety of their other products, and was not simply focused on the PAI for the new product. The cost of poor quality and not taking inspection findings seriously.

    #4. Interesting to look at the forms 483 issued to Lake Forest IL Hospira sites in 2012 and 2013. The one in 2012 is issued to the SVP of Quality, and the one in 2013 on which the warning letter was based was issued to the President/CEO. Clearly an escalation trying to get someone’s attention and indicative that further action was likely.

    Reply
  2. anonymous insider

    two things that we should talk more about in these circles:

    1. The number and nature of “repeat observations” identified in forms 483. When 70% of the observations have the bolded text that “This is repeat observation from [name the date] inspection(s)”, nothing much good ever comes from this and it tees up future compliance actions. Companies should consider themselves well warned. Looks at the 2012 form 483 issued to IMPAX then the 2013 one…they didn’t appear to get the message the first time around. Many more examples of this, and clearly something that companies and legal firms should keep in mind.

    2. I’ve not paid particular attention to this in the past but will do so in the future…change in the person to whom the form 483 is issued. The particular example here is the 2012 Hospira inspection at Lake Forest IL was issued to the SVP Quality, and the one from February 2013 that was almost immediately followed by a warning letter was issued to the President/CEO. Clearly an escalation and attempt to get their total undivided attention.

    Reply

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