FDA EIR - Monarch PCM, LLC - February 06, 2018

A routine FDA inspection of Monarch PCM, LLC, an Over-the-Counter (OTC) drug manufacturer in Fort Worth, TX, was conducted from January 29 to February 6, 2018. The inspection aimed to assess compliance with 21 CFR 211, Current Good Manufacturing Practice for Finished Pharmaceuticals. The inspection resulted in one formal observation documented on Form FDA 483: the company lacked a written procedure for Annual Product Reviews (APRs) and had not performed these reviews for its OTC drugs in 2017. This violates 21 CFR 211.180(e)(1). Additionally, two discussion issues were noted: the Quality Assurance Manager reviewed their own work on batch and packaging records, and the disposition of product in Corrective Action Reports (CARs) was unclear. Monarch PCM, LLC demonstrated prompt action. Before the inspection concluded, the company implemented a written Annual Product Review procedure, addressing the primary observation. For the discussion issues, management committed to ensuring that Quality Assurance personnel would not review their own documentation and to clarifying product disposition within CARs. All identified issues were corrected prior to the close of the inspection, leading to an inspection classification of Voluntary Action Indicated (VAI). Management was advised that uncorrected conditions could lead to further regulatory action.