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# SSM St. Clare Health Gets FDA-483
- URL: https://www.fdaweb.com/ssm-st-clare-health-gets-fda-483/
- Published: 2024-09-16T12:00:00.000Z
- Updated: 2026-09-14T14:41:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157777

FDA has released a 10-observation Form FDA-483 issued to SSM St. Clare Health Center a for GMP deficiencies documented during a February inspection at an outsourcing facility in Fenton, MO. For example, the agency says the firm failed to establish written procedures for production and process controls. Investigators also found the facility’s aseptic processing areas deficient, specifically its system for monitoring environmental conditions. Additionally, the inspection form said equipment and utensils were not cleaned and maintained at appropriate intervals to prevent contamination, an inadequate number of batches of each drug product were tested to determine an appropriate expiration date, and operations relating to the processing of penicillin were not performed in facilities separate from those used for other drug products. To view the notice, click [here](https://www.fda.gov/media/181823/download?ref=fdaweb.com).