FDA WARNING_LETTER - Lohxa LLC - March 22, 2019

On September 10, 2019, the FDA issued a Warning Letter to Lohxa, LLC, following an inspection from March 12-22, 2019, at their Worcester, MA facility. The inspection revealed significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations included: 1. **Stability Testing (21 CFR 211.166(a)):** The firm assigned 12-month expiration dates to repackaged unit dose drug products without supporting stability data. Although four affected lots were recalled and a commitment was made to cease 12-month expiries, supporting 6-month stability data was not provided. 2. **Equipment Cleaning and Maintenance (21 CFR 211.67(a)):** The firm failed to provide data supporting validated cleaning processes for manufacturing equipment, including a non-dedicated repackaging machine used for multiple drugs, some highly potent. Cleaning procedures were also unavailable. 3. **Investigation of Discrepancies (21 CFR 211.192):** Investigations into complaints, such as leaking cups, were not thorough, lacking review of batch records, examination of retention samples, assessment of packaging operations, and details on complaint receipt.

The