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# 4 Observations in Prisma Health FDA-483
- URL: https://www.fdaweb.com/4-observations-in-prisma-health-fda-483/
- Published: 2023-06-28T12:00:00.000Z
- Updated: 2026-09-14T18:41:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154793

FDA has released the form FDA-483 issued following a 2/23-3/3 inspection at the Prisma Health outsourcing facility in Simpsonville, SC. The four inspection observations were:

- failing to establish procedures to prevent microbiological contamination of drug products purporting to be sterile;
- aseptic processing areas are deficient in that floors and walls are not smooth and/or hard surfaces that are easily cleanable;
- failing to have in writing and fully follow the responsibilities and procedures applicable to the quality control unit; and
- failing to submit a required semi-annual compounded drugs report.