FDA 483 - Central Admixture Pharmacy Services, Inc. - August 25, 2023

The FDA Form 483 inspection identified numerous deficiencies at the facility producing sterile parenteral and injection drug products. The Quality Control Unit's responsibilities and procedures were not in writing or fully followed, failing to ensure drug product quality, strength, identity, and purity. The Quality Unit failed to reject lots not meeting batch yield specifications after visual and AQL inspection (SOP-CAPS-4000688) and did not complete requalification for 31 critical API suppliers (SOP-CAPS-4000343). The firm repeatedly violated its Quality System procedure (SOP-CAPS-4000693, section 6.1) for notifying quality events.

The Quality Unit lacked comprehensive procedures for quality review of audit trails and electronic data, and procedures for maintaining production and control records. It failed to investigate and determine batch release, thoroughly investigate microbiological contamination in critical ISO 5 areas, and conduct timely investigations for customer complaints like a "cloudy syringe" in epidural injections. The Quality Unit also failed to investigate particulate matter in 250 mL bag container-closures and identify deficiencies in the 100% visual inspection process.

The firm lacked adequate written procedures for production and process controls to assure drug product identity, strength, purity, and quality. ISO 5 aseptic operators demonstrated inadequate aseptic technique. Customer complaints involving adverse patient drug experiences were not thoroughly investigated. A method transfer of the