FDA 483 - University Pharmacy, Inc. - February 26, 2013

During an inspection on February 19th, 2013, the FDA observed multiple violations at a facility producing sterile injectable drug products.

**Facility and Operations:** The inspection focused on an ISO 5 sterile core where sterile injectables are produced.

**Violations and Observations:**

1. **Equipment and Utensil Sanitation (21 CFR 211.67(a)):** The ISO 5 sterile hood exhibited significant residue and splatters (amber, white, rust colored) on the perforated air guard, drip pan, ceiling, and work surface crevices. A dusty/fuzzy film was observed, and a pharmacy technician stated some residue had never been cleaned.

2. **Drug Product Testing and Release (21 CFR 211.165(a)):** * Progesterone/Pregnenolone 50mg/2.5mg injection lot 721372 was released without sterility, endotoxin, or potency test results. Documentation for vials filled from bulk was missing. * Progesterone/Pregnenolone 50/2.5 mg/ml lot 716184 was released without potency testing for both active ingredients, with the firm citing validation difficulties for Pregnenolone. * Progesterone/Pregnenolone lot 711102 was released without Pregnenolone potency testing. * Finished sterile