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# 4 Observations on Dynalabs FDA-483
- URL: https://www.fdaweb.com/4-observations-on-dynalabs-fda-483/
- Published: 2020-02-26T12:00:00.000Z
- Updated: 2026-09-14T16:04:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146185

FDA has released the FDA-483 issued following a 9/9-9/26/19 inspection at Dynalabs, a St. Louis, Mo., control testing laboratory. The four inspection observations were: 

- failing to establish and document the accuracy, specificity, and reproducibility of test methods;
- failing to have the written stability program for drug products include reliable, meaningful, and specific test methods;
- failing to record and justify deviations from written specifications, standards, test procedures, and laboratory mechanisms; and
- failing to maintain in writing and fully follow the responsibilities and procedures applicable to the quality control unit.