# FDA 483 - QuVa Pharma, Inc. - April 02, 2014

Source: https://www.keypedia.com/records/483/quva-pharma-inc/85fd12f4-3c3e-41d9-b372-0cf64acf0670

> FDA 483 for QuVa Pharma, Inc. on April 02, 2014. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: QuVa Pharma, Inc.
- Inspection Date: 2014-04-02
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: The FDA Form 483 details numerous deficiencies at a compounding pharmacy producing sterile injectable human drugs.

**Facility and Operations:** The pharmacy processes over 116 different sterile injectable drug formulations.

**Violations and Observations:**
*   **Aseptic Technique & Procedures:** Pharmacy technicians exhibited poor aseptic technique, including reaching over open vials, placing non-sterile crates on workbenches, and using a hand-held phone in the aseptic area. Procedures for media fills and gowning were inadequate or non-existent.
*   **Sterilization & Equipment Qualification:** No media fills had been performed for any of the 116+ sterile formulations. Autoclaves and dry-heat ovens lacked equipment qualification to demonstrate microbial/endotoxin log reduction, relying only on run verification. Materials were hand-carried through the cleanroom without further aseptic protection.
*   **Product Testing & Release:** 16 products containing preservatives were not tested for preservative content. Several products were released with potency failures outside acceptance ranges (e.g., Promethazine 113%, Hydrocortisone Acid Zinc 48%).
*   **Investigation of Production Errors:** Investigations into non-conformances, such as dark specks in Morphine, lacked adequate documentation and characterization (e.g., no microscopic examination).
*   **Personnel Gowning:** Technicians did not wear sterile mouth or face covers, exposing skin to open drug product containers. No written procedure required

## Related Documents

- [483 - 2014-06-20](https://www.keypedia.com/records/483/quva-pharma-inc/47aa03ba-b04e-4926-a794-a4b6ec4de663)
- [EIR - 2022-06-16](https://www.keypedia.com/records/eir/quva-pharma-inc/7a53b3eb-2150-4f37-97c5-34f7cbfe4aa1)
- [483 - 2015-01-23](https://www.keypedia.com/records/483/quva-pharma-inc/8e479d93-55b2-4960-b0a3-8f086815d70d)
- [483 - 2022-06-16](https://www.keypedia.com/records/483/quva-pharma-inc/ab15d9bd-3c3c-4119-b29d-a26e304a890b)
- [483 - 2016-12-08](https://www.keypedia.com/records/483/quva-pharma-inc/e7c58cc6-8304-425b-9536-979bf8fd50f5)

## Related Officers

- [Scott T. Ballard](https://www.keypedia.com/people/scott-t-ballard/09b2ae9a-3b30-45bd-bac1-437365e938da)
- [Investigator](https://www.keypedia.com/people/darla-j-christopher/64d3f47f-f3c0-4cfd-a3e8-4dc0e69d04bd)

Company: https://www.keypedia.com/companies/quva-pharma-inc/d524a08a-f9a6-49fd-8b83-e0508a9163f9

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9