FDA WARNING_LETTER - Bershtel Enterprises LLC dba WePackItAll - November 01, 2018

The FDA inspected Bershtel Enterprises LLC dba WePackItAll from October 15 to November 1, 2018, identifying significant CGMP violations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Failure to prevent microbiological contamination and validate sterile processes (21 CFR 211.113(b) & 211.42(c)(10)):** The firm manufactured a multi-dose, preservative-free, homeopathic ophthalmic drug product without adequate sterility controls. The filling suite was unsuitable for sterile drugs, lacking proper surfaces, HEPA-filtered air, environmental monitoring, cleaning systems, and equipment maintenance for aseptic conditions. The firm also lacked sterilization procedures and admitted to not being equipped for sterile drug production, even using a "waiver" for non-sterile filling. FDA lab analysis confirmed contamination with *Bacillus spp.* and particulate matter, leading to a product recall. The firm's response was inadequate, failing to acknowledge its CGMP responsibility and provide plans for screening drug products. 2. **Failure to investigate discrepancies (21 CFR 211.192):** The firm released ophthalmic drug product despite visible contaminants ("white specs") without a thorough root cause investigation, relying on an inadequate assumption that limited testing assured safety. The firm also lacked a comprehensive system for investigating deviations, OOS results, and complaints. 3.