Fagron Group B.V.
FDA issued a warning letter to Fagron Group B.V. (via its Saint Paul, Minnesota facility) following a November 2021 inspection that found significant CGMP deviations in the repackaging and relabeling of active pharmaceutical ingredients, including testosterone, estradiol, and opioids. Key violations included failure to conduct adequate cleaning validation to prevent cross-contamination, failure to investigate out-of-specification results, and failure of the quality unit to exercise proper oversight including unrestricted data deletion on CGMP-related equipment. FDA warned that failure to correct these deviations may result in seizure, injunction, withholding of export certificates, and denial of new drug applications.
Flagged claims (1)
your API are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B)
Required actions (5)
After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any deviation and to prevent their recurrence.
A comprehensive, independent retrospective assessment of your cleaning effectiveness to evaluate the scope of cross-contamination hazards.
A corrective action and preventive action (CAPA) plan, based on the retrospective assessment of your cleaning program, that includes appropriate remediations to your cleaning processes and practices, and timelines for completion.
Failure to promptly correct these deviations may result in legal action without further notice including, without limitation, seizure and injunction.
FDA may withhold approval of any new applications or supplements listing your firm as a drug manufacturer until any deviations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed your corrective actions.
Does your site contain similar claims?
The free site audit scans your whole site against every entry in this Atlas. Most pharmacy / compounding sites match 3-6 patterns.
Run my free site auditWorried about one specific page, ad, or email? Paste it into the free Claim Checker and see what the FDA and FTC would flag, with the precedent next to each one. No email required.
Check specific copy in the Claim Checker