Dr Retter Ec Wladyslaw Retter
FDA issued a CGMP warning letter to Dr Retter Ec Wladyslaw Retter, a Polish OTC drug manufacturer, citing four significant violations related to manufacturing a homeopathic cream distributed to the United States: lack of process validation (including a ~100,000,000-fold discrepancy in active ingredient concentration versus label claims), failure to conduct identity testing on incoming components, inadequate batch production records, and insufficient laboratory controls for microbiological testing. FDA placed all products from the firm on Import Alert 66-40 as of March 4, 2022, and warned that continued non-compliance may result in refusal of admission of all articles manufactured at the facility into the United States.
Flagged claims (1)
you are manufacturing a drug with approximately 4 C difference in dilution, or 100,000,000 times, the active concentration that the homeopathic drug is purported to possess on the label.
Required actions (4)
FDA placed all products from your firm on Import Alert 66-40 on March 4, 2022.
After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done since our inspection to correct your violations and to prevent their recurrence.
Until you correct all violations completely and we confirm your compliance with CGMP, FDA may withhold approval of any new drug applications or supplements listing your firm as a drug manufacturer.
Failure to correct these violations may also result in the FDA continuing to refuse admission of articles manufactured at Dr Retter Ec Wladyslaw Retter, Warszawa, Poland, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3).
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