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# Carie Boyd Pharma Hit with FDA-483
- URL: https://www.fdaweb.com/carie-boyd-pharma-hit-with-fda-483/
- Published: 2024-07-29T12:00:00.000Z
- Updated: 2026-09-14T14:36:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157453

FDA has issued Carie Boyd Pharmaceuticals a six-observation Form [FDA-483](https://www.fda.gov/media/180071/download?ref=fdaweb.com) after inspecting its Irving, TX outsourcing facility last month. Agency investigators found that the firm’s procedures designed to prevent microbiological contamination of sterile drug products were inadequate. The firm was also cited for failing to thoroughly review any unexplained discrepancy associated with a manufacturing batch. Additionally, FDA took issue with Carie Boyd’s procedures for its equipment cleaning and maintenance, and it said that the drug product containers and closures were not clean and sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use.