FDA WARNING_LETTER - Omega Packaging Corp - November 17, 2022

The FDA issued a Warning Letter to Omega Packaging Corp, FEI 2246857, following an inspection from October 18 to November 17, 2022, at their Totowa, NJ facility. The letter identifies significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B). The firm failed to respond to the initial Form FDA 483 observations.

Key violations include: 1. **Inadequate Component Testing (21 CFR 211.84(d)(1) and 211.84(d)(2)):** The firm failed to adequately test incoming components, including ethanol API for methanol and glycerin for diethylene glycol (DEG), relying on unqualified supplier COAs. The ethanol API COA also stated it was not sold as an API. Additionally, the firm lacked data supporting the frequency of water system testing for resistivity and microbiological growth. 2. **Lack of Written Production and Process Control Procedures (21 CFR 211.100(a)):** The firm failed to validate manufacturing processes for drug products and lacked written procedures and validation for their water system, failing to ensure it consistently produces pharmaceutical-grade water. 3. **Inadequate Quality Control Unit Oversight (21 CFR 211.22