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# Stokes Healthcare FDA-483
- URL: https://www.fdaweb.com/stokes-healthcare-fda-483/
- Published: 2021-01-05T12:00:00.000Z
- Updated: 2026-09-14T16:41:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148380

FDA has released the FDA-483 issued following a 9/24-10/9/20 inspection at Stokes Healthcare, a Mount Laurel, NJ, outsourcing facility doing business as Epicur Pharma. The four observations on the form were: 

- failing to justify deviations from written production and process control procedures;
- failing to have written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess;
- failing to establish and follow procedures describing the handling of all written and oral complaints about a drug product; and
- failing to establish time limits when appropriate for completing each production phase to assure the quality of the drug product.