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# 4 Observations in SCA Pharmaceuticals FDA-483
- URL: https://www.fdaweb.com/4-observations-in-sca-pharmaceuticals-fda-483/
- Published: 2023-07-19T12:00:00.000Z
- Updated: 2026-09-14T18:45:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154910

FDA has released the form FDA-483 issued following a 5/2-5/17 inspection at SCA Pharmaceuticals, a Little Rock, AR, outsourcing facility. The inspection observations were:

- aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
- aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure;
- failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has already been distributed; and
- equipment used in the manufacture, processing, packing, or holding of drug products is not of appropriate design to facilitate operations for its cleaning and maintenance.