FDA 483 - Stokes Healthcare Inc. dba Epicur Pharma - February 12, 2016

On February 12, 2016, the FDA issued a Form 483 to Stokes Pharmacy, a producer of drug products located at 18000 Horizon Way, Suite 700, Mount Laurel, NJ 08054, following an inspection conducted from January 27, 2016, to February 12, 2016. The report was issued to Emmett McVey, RPh, Lead Pharmacist and Co-owner.

The inspection revealed four observations:

1. **Facilities and Equipment System Deficiencies:** * **Observation 1:** Separate or defined areas to prevent contamination or mix-ups are deficient for aseptic processing. Specifically, two ISO-5 laminar flow hoods in the same ISO-7 cleanroom are used for both cytochemical (negative pressure typically required) and non-cytochemical sterile drug products. This design creates a risk of cross-contamination, particularly of non-cytochemical products by cytochemicals. * **Observation 2:** Equipment in the ISO-7 cleanroom is not of appropriate design for easy cleaning and maintenance. Examples include three vinyl chairs with wheels and two portable power strips with multiple cords on the floor.

2. **Materials System Deficiencies:** * **Observation 3:** Written procedures for the identification, handling, and approval of closures are not followed. The firm intermittently mismatched aqueous and