AMMD Labs, LLC – FDA Warning Letter, Sep 14, 2018

The FDA issued a Warning Letter to AMMD Labs, LLC following a September 10-14, 2018 inspection of their Pompano Beach, FL drug manufacturing 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 include: - **Lack of Finished Product Testing:** Failure to test finished drug products for identity or potency of active ingredients, and inadequate microbial testing (e.g., no growth promotion testing of media, failure to inactivate preservatives). - **Unvalidated Production Processes:** No process validation studies or ongoing monitoring to ensure consistent drug quality. - **Inadequate Water System Control:** The water system had a dead leg and lacked validation studies, failing to consistently produce pharmaceutical-grade water. - **Insufficient Stability Data:** Lack of adequate stability data to support three-year expiration dates for drug products. - **Inadequate Quality Unit (QU):** The QU failed to adequately test or evaluate raw materials and lacked sufficient authority and resources.

The company's responses to the Form FDA 483 were deemed inadequate, lacking sufficient detail on corrective actions, timelines, and impact assessments. The FDA strongly recommended engaging a qualified CGMP consultant to assist with compliance and conduct a comprehensive audit.

Additionally, the letter noted that the company's