FDA 483 - Almac Pharma Services Limited - November 28, 2025

During an inspection conducted from January 16 to February 10, 2014, the U.S. Food and Drug Administration (FDA) cited P.F.R.immer, Inc., a human drug manufacturer and repackager located in Eatontown, NJ, for multiple significant deviations from current Good Manufacturing Practice (CGMP) regulations, as outlined in an FDA Form 483. The inspection revealed seven observations, many of which were repeat findings from a previous inspection in 2012, indicating persistent systemic issues. Key violations included a failure to adequately investigate Out-of-Specification (OOS) results for Lidocaine HCl 2% Gel, lacking root cause analysis and impact assessment. The firm also failed to follow its written stability testing program by omitting required pH tests for drug lots. Furthermore, P.F.R.immer, Inc. did not test each component, such as Lidocaine HCl, for identity prior to use, instead relying solely on supplier certificates of analysis. Similarly, finished drug products were released without testing for the active ingredient's identity. Additional observations highlighted the absence of cleaning validation for manufacturing equipment and insufficient documentation of cleaning processes, raising concerns about potential cross-contamination. Critical deficiencies in personnel training were noted, with no documented CGMP training for employees in production, quality control, or even the President. Finally, the Quality Control Unit lacked written procedures for its essential responsibilities, including material approval and production record review. These issues collectively indicate a need for comprehensive corrective actions to ensure compliance with 21 CFR regulations and safeguard drug product quality and safety.