# FDA 483 - Stokes Healthcare Inc. dba Epicur Pharma - June 19, 2018

Source: https://www.keypedia.com/records/483/stokes-healthcare-inc-dba-epicur-pharma/3f3b976b-b1f5-4d35-8f74-2555f1ff9f2b

> FDA 483 for Stokes Healthcare Inc. dba Epicur Pharma on June 19, 2018. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Stokes Healthcare Inc. dba Epicur Pharma
- Inspection Date: 2018-06-19
- Product Type: Drugs
- Office Name: New Jersey District Office
- Summary: On June 19, 2018, the FDA issued a Form 483 to Stokes Healthcare Inc., an outsourcing facility located at 8000 Commerce Parkway, Suite 600, Mount Laurel, NJ 08054-2211, following an inspection conducted from May 29 to June 19, 2018. The inspection identified five observations.

1.  **Inadequate Drug Product Testing and Release:** The firm's testing and release of drug products for distribution do not include appropriate laboratory determination of satisfactory conformance to final specifications, identity, and strength of each active ingredient.
    *   Potency testing is not routinely performed, contrary to SOP 9.120, Version 1.3, Step 9.7. For example, Tacrolimus AQ 0.03% Ophthalmic Suspension (Lot 12012017@41, re-labeled as Lot 01122018@96) lacked potency testing.
    *   Drug product samples are not always submitted to a contract laboratory for sterility and endotoxin testing. An in-house sterility test using a non-validated analytical method is performed instead. For example, Voriconazole 1% Ophthalmic Solution Lot 03012018@7 was not sent for external sterility and endotoxin testing.

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## Related Documents

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- [483 - 2023-10-25](https://www.keypedia.com/records/483/stokes-healthcare-inc-dba-epicur-pharma/322e015d-e2aa-4f10-8ee7-c12e3d1f7063)
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## Related Officers

- [Russell J. Glapion](https://www.keypedia.com/people/russell-j-glapion/54dd6274-563a-44fe-8016-2ebd700be7a0)

Company: https://www.keypedia.com/companies/stokes-healthcare-inc-dba-epicur-pharma/5690f008-b17d-45e0-8976-d917b007f02f

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248