GMP Inspection Surfaces Alleged Record Falsification

This one is OTT. FDA inspected a South Korean drug manufacturer and found major GMP violations, including some alleged falsified records issues.

From warning letter. “Pages were removed from your logbook and replaced with newly fabricated pages. Your microbiology team leader admitted to using a knife to remove completed pages from the logbook. Logbook pages were then manipulated to look like the originals, and the microbiology team leader instructed the analyst to backdate and omit testing information related to bioburden samples. Your response indicates that multiple personnel involved in data manipulation are no longer employed at your firm, and you have established a data integrity team to help oversee microbiology laboratory data practices. We also acknowledge that you are using an independent third-party consultant to audit your operation and assist in meeting FDA requirements. Your response is inadequate because it does not provide a corrective action and preventive action (CAPA) plan with sufficient actions to systemically implement management oversight and assure data integrity.”

Asa comments:
Wow, just wow! This takes data integrity violations to a whole new level.
When I ran a supplement manufacturing facility, one simple lesson around GMP records was that corrections should always be transparent. Don’t erase or hide the original entry. Make the correction according to your SOP, and document who made it and when.

Here, FDA describes pages being cut out of a logbook, recreated, backdated and testing information intentionally omitted. That’s falsification.

I also found FDA’s response particularly interesting. Even though the employees involved were no longer with the company and the firm had brought in a third-party consultant, FDA still found the response inadequate because it lacked a sufficient CAPA and management oversight plan. Removing the people involved doesn’t fix a broken system. When a serious GMP problem occurs, companies need to show, with documented corrective actions, how they will prevent it from happening again.

From warning letter, “During the walkthrough of your microbiology laboratories, we found 1,897 blank uncontrolled CGMP-related forms.”

Asa comments: GMP forms should be controlled to prevent inadvertent duplication or worse. This is a lot of uncontrolled forms!

These and several other serious issues led FDA to recommend a voluntary recall of drugs manufactured at the facility that remained in U.S. distribution, and FDA placed the firm’s drugs on Import Alert 66-40. Read the full warning letter here.

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