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# SCA Pharmaceuticals FDA-483
- URL: https://www.fdaweb.com/sca-pharmaceuticals-fda-483/
- Published: 2020-02-11T12:00:00.000Z
- Updated: 2026-09-14T16:02:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146057

FDA has released the FDA-483 issued following a 10/8-11/19/19 inspection at SCA Pharmaceuticals, a Windsor, CT, outsourcing facility. The two inspection observations were: 

- 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
- failing to test through appropriate laboratory testing each batch of drug product required to be free of objectionable microorganisms.