FDA 483 - Yusef Manufacturing Laboratories, LLC - September 13, 2019
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 36722c46-4616-4fd6-904a-718bd55c2753