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

The FDA Form 483 details significant deficiencies at a pharmaceutical firm manufacturing drug products for human and animal use, including Tacrolimus AQ and Fluorouracil.

**Key Violations and Observations:**

* **Lack of Process Validation:** The firm failed to validate manufacturing processes for Tacrolimus AQ (human and animal use since July 2022, (b)(4) lots released) and Fluorouracil (human and animal use since February 2023, (b)(4) lots released). No process validation protocols or sampling plans exist to demonstrate consistency. * **Aseptic Processing Deficiencies:** * No smoke studies or media fills conducted under dynamic conditions in aseptic filling rooms C704 and C706. * Existing smoke study (b)(4) did not include critical operations (e.g., (b)(4) operations in (b)(4) containers, assembly of sterile filling equipment). * Media fill protocol PR-23-0001 omitted key aseptic processing aspects (e.g., aseptic filling of (b)(4) and Tacrolimus (b)(4) concentrate, mixing with (b)(4), use of (b)(4) for protection of media bottles). * Discrepancy between media fill protocol and master batch records regarding the use of (b)(4) for protection during transfer. *