Pacira Pharmaceuticals, Inc. – FDA EIR, Mar 1, 2018

An FDA inspection of Pacira Pharmaceuticals, Inc.'s San Diego facility was conducted from February 21 to March 1, 2018. This routine surveillance inspection of a sterile drug manufacturer assessed all six quality systems —quality, production, materials, facilities and equipment, laboratory, and packaging and labeling —under applicable Good Manufacturing Practice (GMP) regulations for sterile drug products. The inspection resulted in six significant observations detailed in a Form FDA 483. Main violations included inadequate investigation of unexplained product discrepancies and batch failures to meet specifications. Deficiencies were noted in written cleaning and maintenance procedures, which lacked sufficient detail on methods, equipment, and materials. Laboratory controls were deemed inadequate for assuring drug product identity, strength, quality, and purity, specifically concerning the validation of closure supplier test results. Furthermore, the company failed to establish and follow appropriate written procedures to prevent microbiological contamination of sterile drug products, including validating aseptic and sterilization processes. Production and process control procedures were also found not to be consistently followed. Additionally, the inspection highlighted deficiencies in the visual inspection training of an operator. Pacira Pharmaceuticals, Inc. committed to submitting a written response to the FDA 483 within 15 business days, outlining corrective actions for the identified issues.