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# Stokes Healthcare FDA-483
- URL: https://www.fdaweb.com/stokes-healthcare-fda-483-2/
- Published: 2018-07-10T12:00:00.000Z
- Updated: 2026-09-15T00:18:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141830

FDA has released the FDA-483 issued following a 5/29-6/19 FDA inspection at Stokes Healthcare, a Mount Laurel, NC, outsourcing facility. Specific inspection observations were: 

- testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and the identity and strength of each active .ingredient prior to release;
- results of stability testing are not used in determining expiration dates;
- master production and control records lack complete manufacturing and control instructions and sampling and testing procedures;
- labels of some of the facility’s drug products do not include required information; and
- the facility has not submitted a compounded drug product report to FDA upon initial registration as an outsourcing facility.