FDA 483 - Yusef Manufacturing Laboratories, LLC - September 13, 2019

Yusef Manufacturing Laboratories, LLC in Clearfield, UT, received a Form 483 with three repeat observations. The inspection revealed significant issues including the distribution of drug products that were not properly tested for identity and strength, failure of the quality control unit to approve product releases, and a lack of a written stability testing program to support product expiration dating. These findings indicate a serious lack of adherence to quality control and testing procedures for drug products.