Purolea Cosmetics Lab
FDA issued a warning letter to Purolea Cosmetics Lab (Livonia, MI) after a October 2025 inspection found the facility manufacturing adulterated homeopathic drug products under insanitary conditions, with multiple CGMP violations including failure to conduct microbiological testing, component identity testing, and adequate quality unit oversight. Two products — 'Dermveda Extra Strength Shingles Relief' and 'Dermveda Extra Strength Ultra Genital Herpes Relief' — were identified as unapproved new drugs marketed for serious conditions (shingles and genital herpes) without FDA approval. The firm also improperly relied on AI-generated compliance documents without human QU review. FDA warned that failure to address violations may result in seizure, injunction, and withholding of approvals, and required a written response within 15 working days.
Flagged claims (2)
SHINGLES
GENITAL HERPES RELIEF
Required actions (6)
After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence.
Specify by National Drug Code (NDC) number which drugs have been discontinued and the last day of manufacture.
Clarify your intentions for the drug products that remain on the market within expiry.
Provide commitment that if you intend to resume manufacturing drugs at this facility or any other facility in the future, that you will notify this office prior to resuming your drug manufacturing operations.
Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.
Confirm that if you receive any client or customer complaints and/or any results from ongoing testing or evaluation that reveal substandard quality for the drug components, active pharmaceutical ingredient (API), or distributed drug products, that rapid corrective action should be taken for products that were released for commercial distribution and that are still within expiry, such as notifying customers and product recalls.
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