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# SCA Pharma Issued 10-Item FDA-483
- URL: https://www.fdaweb.com/sca-pharma-issued-10-item-fda-483/
- Published: 2023-11-29T12:00:00.000Z
- Updated: 2026-09-14T14:17:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155877

FDA has released a [10-item Form FDA-483 ](https://www.fda.gov/media/174049/download?ref=fdaweb.com)related to an inspection last month at SCA Pharmaceuticals’ Windsor, CT outsourcing facility that cited significant GMP deficiencies. For example, the agency took issue with the firm’s lack of quality control efforts because it does not require identification of particulates found during the visual inspection process. The company was also cited for not determining the actual product yield and percentages of theoretical yield at the conclusion of each appropriate manufacturing phase.

Additionally, FDA investigators found that SCA failed to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet specifications, whether or not the batch has been already distributed. And they said written procedures are not established and followed for equipment cleaning and maintenance.