FDA 483 - Monarch PCM, LLC - February 06, 2018

An FDA inspection of Monarch PCM LLC in Fort Worth, TX, a drug manufacturer, revealed a significant lapse in quality control procedures. The firm failed to establish written procedures for Annual Product Reviews (APRs) and did not conduct these reviews for its Over-the-Counter human drugs in 2017. This indicates a serious deficiency in ensuring ongoing product quality and compliance.