FDA WARNING_LETTER - Similasan AG - April 04, 2023

The FDA issued a Warning Letter to Similasan AG following an inspection from March 27 to April 4, 2023, identifying significant violations. The company's ophthalmic products, including "Similasan Dry Eye Relief" and "Similasan Pink Eye Relief," are deemed unapproved new drugs under section 505(a) of the FD&C Act, as they lack FDA approval and are not generally recognized as safe and effective for their intended uses, despite being labeled as homeopathic.

Furthermore, the facility exhibited significant Current Good Manufacturing Practice (CGMP) violations, rendering its drug products adulterated. Deficiencies include: 1. **Failure to prevent microbiological contamination (21 CFR 211.113(b)):** Media fills did not accurately simulate commercial manufacturing, with insufficient representation of aseptic interventions. 2. **Inadequate laboratory controls (21 CFR 211.160(b)):** The firm failed to conduct 100% visual inspection for particulates in ophthalmic products, relying instead on AQL sampling, and lacked documentation for routine osmolarity testing. 3. **Incomplete laboratory records (21 CFR 211.194(a)):** Negative controls for sterility testing were not documented concurrently. 4. **Inadequate quality unit (21 CFR 211.22(a) and 211.22(