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# 7 Observations on SCA Pharmaceuticals FDA-483
- URL: https://www.fdaweb.com/7-observations-on-sca-pharmaceuticals-fda-483/
- Published: 2025-01-21T12:00:00.000Z
- Updated: 2026-09-14T14:51:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158518

FDA has released the form FDA-483 issued following a 12/2-12/20/2024 inspection at SCA Pharmaceuticals, a Windsor, CT, outsourcing facility. The seven inspection observations were:

- failure to thoroughly review any unexplained discrepancy whether or not the batch had already been distributed;
- failure to establish written procedures for production and process controls to assure that drug products have the identity strength, purity, and quality that they are purported or represented to possess;
- failure to have written procedures for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing, or holding of a drug product;
- equipment used in the manufacture, processing, packing, or holding of drug products is not of appropriate design to facilitate operations for its intended use and cleaning and maintenance;
- failure of batch production and control records to include complete information relating to the production and control of each batch;
- failure to establish and follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile; and
- aseptic processing areas are deficient regarding the systems for monitoring environmental conditions.