FDA WARNING_LETTER - Dr Retter Ec Wladyslaw Retter - March 04, 2022

The FDA issued a Warning Letter to Dr. Retter Ec Wladyslaw Retter, a Polish manufacturer of OTC drug products, following a review of submitted records in response to a June 2, 2021, request. The facility's drug products are deemed adulterated due to significant violations of current good manufacturing practice (CGMP) regulations (21 CFR, parts 210 and 211).

Key violations include: 1. **Failure to establish adequate written procedures for production and process control (21 CFR 211.100(a) and (b))**: The firm distributed a homeopathic drug, (b)(4) cream, to the U.S. without adequate process validation. The product label stated (b)(4) C, but manufacturing records indicated a concentration approximately 4 C different, or 100,000,000 times, the active concentration. A validation protocol did not exist, and temperature discrepancies were noted in manufacturing records. 2. **Failure to conduct identity testing for drug product components (21 CFR 211.84(d)(1))**: The firm relied on organoleptic examination or supplier COAs without conducting specific identity tests for incoming raw materials or validating supplier analyses. 3. **Failure to prepare complete batch production and control records (21 CFR 211.188(b))**: