FDA 483 - Actavis Laboratories FL, Inc. - May 25, 2021

Actavis Laboratories FL, Inc. in Davie, FL, received a Form 483 with five observations during an FDA inspection. The firm demonstrated significant deficiencies in its quality control investigations, including inadequate root cause analysis and product impact assessments for out-of-specification results. Additional issues included a lack of microbial testing for certain non-sterile drug products, failure to maintain equipment calibration, incomplete master batch records, and deficient procedures for handling customer complaints.