FDA Flags Sterility/Quality Control at SCA Pharma

FDA has cited SCA Pharmaceuticals for multiple deficiencies in sterile drug manufacturing practices following a 10-day inspection of the company’s outsourcing facility in Little Rock, AR, according to a just-released Form FDA-483. The 10/20-30 inspection raised concerns about microbiological controls, aseptic processing, and the company’s handling of contamination events involving injectable drug products.

According to the report, SCA Pharmaceuticals failed to establish adequate procedures to prevent microbiological contamination of sterile drugs, particularly with respect to monitoring personnel working in critical aseptic environments. FDA investigators cited video evidence showing technicians performing key operations inside an ISO-classified laminar flow hood during aseptic filling without being monitored for potential microbial contamination.

The agency also found deficiencies in the facility’s aseptic processing areas, noting that SCA had not conducted airflow visualization, or “smoke,” studies for all laminar flow hoods used in sterile production. Such studies are considered essential to demonstrate that high-efficiency particulate air (HEPA)–filtered air is flowing properly to protect sterile products during manufacturing.

In another observation, FDA said the company failed to adequately investigate microbial contamination events before distributing portions of affected drug batches. In several cases, SCA concluded that contamination stemmed from improperly sanitized materials and rejected only part of the affected batch, while releasing earlier portions for distribution. FDA inspectors said the firm did not demonstrate that contamination was limited to the rejected portions, despite the same sanitization processes being used throughout production.

The inspection report also identifies multiple microbial excursions linked to organisms such as Bacillus species and Penicillium citrinum, which the firm attributed to improper sanitization of materials transferred into critical production areas. FDA noted that SCA distributed multiple lots of injectable drugs associated with those contamination events, including ketamine hydrochloride and phenylephrine hydrochloride prefilled syringes, some with beyond-use dates extending into 2026.

Additionally, inspectors cited deficiencies in laboratory controls and visual inspection procedures. The agency said SCA’s defect classification system did not adequately distinguish between types of particulate matter found in drug solutions and improperly categorized some foreign materials as minor defects, despite the potential risk to sterility and patient safety.