FDA 483 - SCA Pharmaceuticals, LLC - December 20, 2024

This FDA Form 483 was issued to SCA Pharmaceuticals, LLC, an outsourcing facility located at 755 Rainbow Rd Ste B, Windsor, CT, following an inspection from December 2 to December 20, 2024. The inspection revealed seven observations related to quality system and manufacturing deficiencies.

Observation 1 notes a failure to thoroughly review unexplained discrepancies, specifically regarding over 1200 documented supplier concern reports since November 2023 of foreign material (cardboard, hair, fiber) in sterile syringe tray packs from suppliers. The firm continued to use these syringes, leading to rejections in batches of Phenylephrine HCl and Rocuronium Bromide. This issue was a known finding from a 2019 supplier qualification.

Observation 2 indicates a failure to establish written procedures for production and process controls to assure drug product identity, strength, purity, and quality. The firm failed to adequately validate manufacturing processes for sterile injectable products across multiple lines (e.g., Vancomycin, Potassium Chloride, Norepinephrine), with approximately 24 manufacturing investigations classified as "Confirmed for potency OOS" representing 34 lots from October 2023 to December 2024. The firm failed to address root causes of "variable potency results" or demonstrate process capability.

Observation 3 highlights a lack of written procedures for cleaning and maintenance of equipment, specifically for the metal diffusers covering HEPA filters in Lamin