# FDA 483 - Stokes Healthcare Inc. dba Epicur Pharma - October 25, 2023

Source: https://www.keypedia.com/records/483/stokes-healthcare-inc-dba-epicur-pharma/9872ca1f-dfc5-49af-9c44-be3a98afa7d6

> FDA 483 for Stokes Healthcare Inc. dba Epicur Pharma on October 25, 2023. 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: 2023-10-25
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: During an inspection from September 26 to October 25, 2023, the FDA observed significant deficiencies at Stokes Healthcare Inc. dba Epicur Pharma, an outsourcing facility in Mount Laurel, NJ. The inspection revealed widespread issues including unvalidated manufacturing processes for sterile drug products, inadequate aseptic processing controls, failures in quality control investigations, and non-compliant drug product labeling. These findings indicate a serious lack of adherence to cGMP requirements, particularly concerning the production and release of sterile human and animal drug products.

## Related Documents

- [483 - 2020-10-09](https://www.keypedia.com/records/483/stokes-healthcare-inc-dba-epicur-pharma/646d510d-14e6-4e7c-a580-140402d4d07a)
- [483 - 2023-10-25](https://www.keypedia.com/records/483/stokes-healthcare-inc-dba-epicur-pharma/322e015d-e2aa-4f10-8ee7-c12e3d1f7063)
- [483 - 2018-06-19](https://www.keypedia.com/records/483/stokes-healthcare-inc-dba-epicur-pharma/3f3b976b-b1f5-4d35-8f74-2555f1ff9f2b)
- [483_RESPONSE - 2016-02-12](https://www.keypedia.com/records/483_response/stokes-healthcare-inc-dba-epicur-pharma/ff6c5f6c-a91d-486c-bc6a-dd39171988dd)
- [483 - 2025-05-23](https://www.keypedia.com/records/483/stokes-healthcare-inc-dba-epicur-pharma/161464fa-1ba5-4c72-b1f2-be17c4e08da3)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/christina-k-theodorou/3c18d958-14de-4f25-9fbd-7358205155f7)
- [Yoriann M. Cabrera Bartolomei](https://www.keypedia.com/people/yoriann-m-cabrera-bartolomei/3f827fbc-dcd1-4698-9bae-e0e93b900d08)
- [Ruben C. Quintana](https://www.keypedia.com/people/ruben-c-quintana/fbf0f0ef-eb51-4a06-a4b9-f7856fa06c58)

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