FDA 483 - Lex, Inc. - February 14, 2018
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.
Lex, Inc., a drug manufacturer in Medley, FL, was cited with seven observations during an FDA inspection from January 30 to February 14, 2018. The inspection revealed significant deficiencies in quality control, laboratory practices, and manufacturing processes. Key issues included inadequate investigations into out-of-specification results, failure to follow stability testing programs, incomplete laboratory records, and a lack of process validation and equipment qualification.
ID · 8e773945-fc6e-49f7-a50d-c7a3b0575c4f