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

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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