Drugs

FDA Cites SCA Pharmaceuticals Over Sterility, Contamination Control

FDA has cited SCA Pharmaceuticals for multiple manufacturing and contamination-control deficiencies at its outsourcing facility in Windsor, CT, including failures involving sterile compounding practices, particulate contamination investigations and environmental monitoring.

According to a just-posted FDA Form 483 issued following an inspection conducted in March, investigators found that procedures intended to prevent microbiological contamination of sterile drug products “are not established and followed.” The agency said the company initiated approximately 46 excursion reports tied to microorganisms recovered from ISO-5 critical areas in laminar flow hoods used to compound sterile drug products. Since 12/2024, organisms identified in the facility included multiple Staphylococcus species, Bacillus species, Corynebacterium tuberculostearicum, Micrococcus luteus and other bacteria and fungi, including Penicillium citrinum and Cladosporium.

FDA said the contamination events affected batches of multiple sterile products, including phenylephrine, oxytocin, succinylcholine chloride, fentanyl citrate, labetalol, rocuronium bromide, hydromorphone and diltiazem products, as well as a media fill batch. While some batches were rejected, at least one affected batch was released, according to the inspection report.

Investigators also observed what they described as poor aseptic practices inside ISO-5 laminar flow hoods and ISO-7 manufacturing environments. The agency additionally raised concerns about the company’s use of air sampling equipment and sterile goggles in classified cleanroom areas, saying the firm had not adequately demonstrated that the equipment and gowning components would not interfere with first-air protection or introduce particulates into sterile environments.

FDA also cited the company for failing to adequately investigate recurring particulate contamination in sterile drug products. According to the inspection report, SCA Pharmaceuticals initiated approximately 110 deviation investigations since 12/2024 related to particulate matter observed during visual inspections, including material on syringe plungers, floating particulates and contamination adhered to stopper barrels. The agency said the company failed to determine definitive root causes for the contamination events or implement effective corrective and preventive actions to prevent recurrence.

“The repeated occurrence of intrinsic particulate failures without adequate investigation and effective CAPA (corrective and preventive action) demonstrates a failure to maintain your manufacturing process in a state of control,” investigators wrote in the Form 483.

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