Avoiding FDA 483s Strategy #1: Document, Document, Document

In one extreme case, an FDA inspection concluded that Zorro Technology didn’t have written quality control procedures at all, that drug ingredients weren’t identified in terms of their status, and that batch records identifying the weight of compound quantities to be added weren’t present.

documentsOf late, inspectors are getting tougher about documentation requirements. In some cases, inspectors actually sit down in front of your computer and search through your documentation themselves. Not only that, in a relatively new twist, they’re requiring photographs of the plants they inspect and demanding CDs containing all of the documents they want to review.

Once they’ve done their doc review, get ready. When the inspectors ask to see specific pieces of documentation, you’d better be ready to turn them over pronto.

According to one expert, one company was recently cited with a 483 simply because they didn’t turn over documents quickly enough—and the inspector had demanded quite a lot of them.

The bottom line: Make sure you have qualified people in control of document flow.

Slip-ups here can lead not only to 483s, but also a tougher investigation overall.

“If an investigator asks for documents and the firm waffles, the investigators are going to get upset and may even wonder if the firm is going to fake them later,” according to a consultant who works with biopharma firms.

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One thought on “Avoiding FDA 483s Strategy #1: Document, Document, Document

  1. Tony Chen Post author

    Got this from an anonymous insider today on this topic of failing to produce documents in a timely manner:

    You might want to take a look at the draft guidance included here, Draft Guidance for Industry; Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection (FR Vol. 78 No. 135, page 42387, July 15, 2013), relative to the posting today on FDAzilla. This is a guidance supporting one of the new powers given to FDA in Section 707 of FDASIA last year. Briefly, FDA can deem products adulterated if the firm delays, denies, limits or refuses an inspection. This draft guidance is dated July 12, 2013. On July 1, 2013 FDA issued a warning letter to Fresenius Kabi Oncology Ltd where they “remind” the firm of the content of section 707 of FDASIA, and give specific examples of how the inspection in question was delayed and information denied (at least temporarily). An even better example of instances in which FDA intends to use this power is provided in the warning letter issued to Wockhardt Limited on July 18, 2013. Here the FDA provides a variety of examples of how FDA deemed that the firm impeded the inspection. So while FDA does get suspicious of delays in providing documents, I think in general this power is going to be used in the more egregious cases demonstrated in these two warning letters. Companies would be well served to read these two warning letters to see that FDA is implementing these new powers from FDASIA.

    The warning letters in question are posted on the FDA website in their warning letter section.

    Reply

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