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

Source: https://www.keypedia.com/records/483/university-pharmacy-inc/fde9aea9-bfaa-421d-a18f-93b90dc06be7

> FDA 483 for University Pharmacy, Inc. on February 26, 2013. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: University Pharmacy, Inc.
- Inspection Date: 2013-02-26
- Product Type: Drugs
- Office Name: Denver District Office
- Summary: 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

## Related Documents

- [STATE_REFERRAL_LETTER - 2013-02-22](https://www.keypedia.com/records/state_referral_letter/university-pharmacy-inc/a42ef0b3-6457-4bd4-b66e-07775ba66bc2)

## Related Officers

- [Compliance Officer / Investigator](https://www.keypedia.com/people/erika-v-butler/3e654530-4c29-403d-880e-a5422315c3c0)

Company: https://www.keypedia.com/companies/university-pharmacy-inc/fc50a96a-f1c7-4388-8f99-4bb0076d72ce

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face