Anicare Pharmaceuticals Pvt Ltd. – FDA Warning Letter, Aug 3, 2018

The FDA inspected Anicare Pharmaceutical Pvt. Ltd. from July 30 to August 3, 2018, identifying significant Current Good Manufacturing Practice (CGMP) violations, rendering drug products adulterated. The firm failed to establish an adequate stability testing program (21 CFR 211.166(a)), lacked proper quality control unit review and approval of production procedures, including process validation and water system control (21 CFR 211.100(a)), and had inadequate equipment cleaning and maintenance procedures (21 CFR 211.67(b)).

Additionally, Lucky SuperSoft Hydrocortisone Anti-Itch Cream and U Hydrocortisone 1% Anti-Itch Cream were deemed unapproved new drugs (21 U.S.C. 355(a)) due to non-compliant formulations and labeling, such as unapproved active ingredients (aloe) and indications. Numerous other OTC products (Budpak, Lucky SuperSoft, U brands) were misbranded (21 U.S.C. 352(c) and (x)) for failing to include a complete statement of identity (e.g., missing menthol), lacking Spanish "Drug Facts" panels for dual-language labels (21 CFR 201.15), and not disclosing a domestic address or phone number for adverse event reporting.

The FDA recommended engaging a CGMP consultant and requires the firm to investigate all violations, determine root causes, and implement comprehensive corrective actions within 15 working days. Failure to comply may result in withheld approvals, import alerts, and continued prohibition of product introduction into interstate commerce.