FDA 483 - SCA Pharmaceuticals, Inc. - October 20, 2025

During an FDA inspection from October 20-30, 2025, SCA Pharmaceuticals, Inc., an outsourcing facility in Little Rock, AR, received an FDA Form 483 detailing four significant observations indicating non-compliance with current Good Manufacturing Practices (cGMP) for sterile drug products. Key issues included a lack of established procedures to prevent microbiological contamination, specifically insufficient monitoring of personnel directly engaging with sterile manufacturing environments during critical operations. The inspection also found deficiencies in aseptic processing area air supply, noting the absence of comprehensive airflow visualization studies in all Laminar Flow Hoods used for sterile production. Furthermore, the firm failed to thoroughly investigate microbial excursions recovered from ISO-classified areas before distributing product batches. Investigations prematurely concluded that contamination was limited to only portions of batches without sufficient supporting evidence, leading to the release of potentially impacted sterile products such as Ketamine HCI and Phenylephrine HCI syringes. Lastly, laboratory controls for product inspection and defect classification were deemed inadequate. The firm"s system inappropriately categorized critical defects, including particulates in drug solutions and foreign material within syringe stopper ribs, as minor. These issues could compromise product sterility and pose serious patient risks. SCA Pharmaceuticals must implement robust corrective actions to address these deficiencies and ensure adherence to federal drug manufacturing regulations.