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# 4 Observations in Medi-Fare Inspection
- URL: https://www.fdaweb.com/4-observations-in-medi-fare-inspection/
- Published: 2024-03-21T12:00:00.000Z
- Updated: 2026-09-14T14:26:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156604

FDA has released the form FDA-483 issued following a 5/15-5/26/2023 inspection at Medi-Fare, a Blacksburg, SC, outsourcing facility. The four inspection [observations](https://www.fda.gov/media/177153/download?ref=fdaweb.com) were:

- reports of analysis from component suppliers are accepted instead of testing each component for conformity with all appropriate written specifications, without establishing the reliability of the supplier’s analyses through appropriate validation of the supplier’s test results at appropriate intervals;
- the identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist;
- samples of representative units were not visually examined for correct labeling after finishing operations; and
- aseptic processing areas are deficient regarding the system for monitoring environmental conditions.