SCA Pharmaceuticals, LLC

FDA's Center for Drug Evaluation and Research issued Warning Letter No. 724202 on September 14, 2026, to SCA Pharmaceuticals, LLC, an outsourcing facility registered under section 503B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 353b) located in Little Rock, Arkansas. The letter follows an FDA inspection conducted from October 20 through October 30, 2025, during which an investigator documented serious deficiencies in the facility's sterile drug manufacturing practices. FDA reviewed the facility's responses to the Form FDA 483 dated November 21, 2025, and December 31, 2025, and found those responses partially inadequate. FDA determined that drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions in violation of section 501(a)(2)(A) of the FDCA, rendering them adulterated. Specific observations included: failure to routinely certify ISO 5 areas including airflow visualization studies under dynamic conditions; failure to take adequate corrective action after microbial contamination was recovered in the ISO 5 aseptic processing area; presence of foreign material between stopper ribs of syringes posing contamination risk to product-contact surfaces; and aseptic technique failures by compounding technicians and aseptic assistants during production of identified lots including Fentanyl Citrate 2 mcg/mL Bupivacaine HCl 0.125% lot 1125035913 and Methadone HCl 10 mg/mL lot 1125035922. Technician violations included moving quickly in critical areas, leaning into hoods, blocking first-pass air, and resting arms on hood work surfaces. FDA also cited CGMP violations under section 501(a)(2)(B) of the FDCA and 21 CFR parts 210 and 211, including failures under 21 CFR 211.113(b) (aseptic process validation), 21 CFR 211.42(c)(10)(iii) (HEPA-filtered positive-pressure air supply), 21 CFR 211.192 (batch failure investigation), 21 CFR 211.160(b) (laboratory controls), and 21 CFR 211.22(d) (quality control unit procedures). Regarding the last violation, the facility's Chief Quality Officer acknowledged that production video recordings used in contamination investigations are overwritten after a defined retention period rather than retained as quality records; an excursion investigation for Ketamine HCl 10 mg/mL lot 1125035065 retained only still images rather than the full video. FDA found several corrective actions deficient. The facility failed to demonstrate that microbial contamination did not affect released portions of batches associated with ISO 5 excursions, failed to initiate corrective and preventive action plans for material sanitization, and maintained an inadequate visual inspection classification system that treated extrinsic particulates as major rather than critical defects, resulting in no investigation of particle events unless a defect rate limit threshold was exceeded. Between April and September 2025, the facility detected particles in multiple lots but investigated only threshold-exceeding events. FDA also found that the classification of foreign material trapped between syringe stopper ribs as a minor defect, subject to a minor defect rate limit, was inadequate given the contamination risk to product-contact surfaces during the syringe filling process.