# FDA 483 - University Rx Specialist, dba University Compounding Pharmacy - September 21, 2015

Source: https://www.globalkeysolutions.net/records/483/university-rx-specialist-dba-university-compounding-pharmacy/cdbdfb5b-b066-4039-b118-aeac60f637f2

> FDA 483 for University Rx Specialist, dba University Compounding Pharmacy on September 21, 2015. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: University Rx Specialist, dba University Compounding Pharmacy
- Inspection Date: 2015-09-21
- Product Type: Drugs
- Office Name: Los Angeles District Office
- Summary: The FDA Form 483 details significant deficiencies in aseptic processing and quality control at a sterile drug product manufacturing facility.

**Environmental Monitoring Deficiencies:**
*   **ISO 5 & ISO 7 Areas:** Lack of active monitoring for differential pressures, routine viable particulate air, and non-viable particulate air during production.
*   **Surface Monitoring:** Insufficient frequency of surface sampling in ISO 5 (not done for each lot) and ISO 7 (only beginning, middle, end of day).
*   **Personnel Monitoring:** Routine personnel glove sampling after daily operations is not conducted.

**Sterility Assurance & Validation Issues:**
*   **Sterility Failure Investigations:** Failure to thoroughly investigate sterility failures in three drug product batches (Glycerin/Lidocaine/Epinephrine injectable Lot 562655, Heparin/Lidocaine Irrigation Lot #593202, Testosterone pellet Lot #618513), with root causes uninvestigated.
*   **Media Fills:** Inadequate media fills lacking growth promotion for media, failing to simulate batch processes for large volume vials (100mL/1000mL), and insufficient detail in records (filling time, personnel, equipment, door movements, total time, incubation temperature).
*   **Clean Hold Time Studies:** Not performed for sterilization glassware.
*   **Sterile Drug Product Grade:** Sterile drug products are not pharmaceutical grade.

## Related Documents

- [483 - 2017-10-27](https://www.globalkeysolutions.net/records/483/university-rx-specialist-dba-university-compounding-pharmacy/0575e725-bc1f-4c9b-82c7-0d5cc4b6931a)

## Related Officers

- [Team Biologics Staff](https://www.globalkeysolutions.net/people/linda-thai/f4d9a1c3-e5e8-4f13-8abe-e1f1e597c8f8)

Company: https://www.globalkeysolutions.net/companies/university-rx-specialist-dba-university-compounding-pharmacy/12a3316a-d0c4-4f6a-9825-89f40e86bdb9

Office: https://www.globalkeysolutions.net/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b