FDA 483 - Lex, Inc. - February 14, 2018

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.