FDA WARNING_LETTER - Legacy Pharmaceutical Packaging LLC - April 27, 2022

The FDA issued a Warning Letter to Legacy Pharmaceutical Packaging, LLC, following an inspection from April 12 to April 27, 2022, at their Earth City, Missouri facility. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated under sections 501(a)(2)(A) and 501(a)(2)(B) of the FD&C Act.

Key violations include: 1. **Inadequate Investigations (21 CFR 211.192):** The firm failed to thoroughly investigate product mix-ups, specifically foreign tablets found in drug products (e.g., (b)(4) tablets containing (b)(4), and (b)(4) tablets containing (b)(4)). Investigations were not extended to other potentially impacted batches, and non-contemporaneous documentation (e.g., cleaning checklists filled out for unperformed work) was not adequately addressed. The FDA deemed the firm's May 17, 2022, response inadequate for not extending investigations or addressing documentation issues. 2. **Insanitary Conditions (21 CFR 211.113(a) and 501(a)(2)(A)):** An operator was observed picking individual tablets off the floor and placing them directly into the feed hopper during active filling operations. The firm's subsequent "event