Fagron Group B.V.

Warning LetterOpen

Mr. Rafael Padilla Chief Executive Officer Fagron Group B.V. Lichtenauerlaan 182 Rotterdam Zuid 3062 ME Holland NetherlandsFEI 1000174332Issued Jun 14, 2022Division of Pharmaceutical Quality Operations III

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 1000174332.

Violations0

Issue DateJun 14, 2022

Product TypeDrugs

StatusOpen

Letter Details

Firm: Fagron Group B.V.
Location: Mr. Rafael Padilla Chief Executive Officer Fagron Group B.V. Lichtenauerlaan 182 Rotterdam Zuid 3062 ME Holland Netherlands
FEI Number: 1000174332
Country: Netherlands
Issue Date: June 14, 2022
Issuing Office: Division of Pharmaceutical Quality Operations III
Product Type: Drugs
Status: Open

Summary

Fagron Group B.V.'s Saint Paul, Minnesota facility was cited for significant deviations from current good manufacturing practice (CGMP) in the production of active pharmaceutical ingredients (APIs), rendering their products adulterated. The company failed to perform adequate cleaning validation studies for non-dedicated production cabins used to repackage highly potent drugs including testosterone, estradiol, betamethasone, tamoxifen, and opioids, creating potential cross-contamination risks. An outdated 2008 cleaning validation study did not reflect current practices, and the company acknowledged the need for revalidation, having only provided preliminary results for niacin and progesterone residue testing during the November 2021 inspection.

Fagron Group B.V. FDA Warning Letter, June 14, 2022