FDA 483 - Dr Marcs Manufacturing and Sales, LLC - April 27, 2018

D. Marcs Manufacturing and Sales, LLC, an own label distributor of drug products in North Hills, CA, was cited for numerous significant deficiencies during an FDA inspection. The firm lacked fundamental quality control systems, written procedures for critical operations like stability testing, complaint handling, and distribution, and failed to ensure proper employee training and drug product storage conditions. These observations indicate a severe lack of basic GMP compliance.