FDA 483 - Monarch PCM, LLC - August 20, 2021

Monarch PCM, LLC was cited for significant deficiencies across its drug product and dietary supplement manufacturing operations. The firm repeatedly released drug products that failed to meet specifications, lacked adequate quality control oversight, and failed to properly investigate and prevent microbial contamination, particularly Burkholderia cepacia complex, in its water systems and equipment. Additionally, the inspection revealed issues with incomplete laboratory records, unvalidated reprocessing procedures, and inadequate product specifications and supplier qualification for dietary supplements.