FDA WARNING_LETTER - A.P. Deauville, LLC - May 02, 2019

The FDA conducted an inspection of A.P. Deauville, LLC from April 9 to May 2, 2019, identifying 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's May 20, 2019 response to the Form FDA 483 was deemed inadequate. Key violations include the failure to thoroughly investigate unexplained discrepancies or failures to meet specifications (21 CFR 211.192), such as out-of-limit water system results and product complaints describing allergic reactions. The firm also failed to establish an adequate quality unit with written and followed procedures (211.22(a)&(d)), leading to uninvestigated manufacturing deviations and a lack of essential procedures. Furthermore, there was a failure to establish written procedures for production and process control (21 CFR 211.100(a)), evidenced by unvalidated manufacturing processes, unqualified equipment, and inadequate water system control. Lastly, the firm failed to clean, maintain, and sanitize equipment and utensils appropriately (21 CFR 211.67(a)), lacking cleaning validation and procedures, with visible residue and leaks. These repeat observations highlight inadequate quality system oversight. The FDA strongly recommends engaging a CGMP consultant. The firm must provide a detailed response within 15 working days outlining corrective actions, or face potential legal action, including seizure, injunction, and impact on federal contracts and product approvals.