# FDA 483 - QuVa Pharma, Inc. - May 31, 2019

Source: https://www.keypedia.com/records/483/quva-pharma-inc/8cd7d039-95c1-4202-b52c-748d3117bb36

> FDA 483 for QuVa Pharma, Inc. on May 31, 2019. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: QuVa Pharma, Inc.
- Inspection Date: 2019-05-31
- Product Type: Drugs
- Office Name: New Jersey District Office
- Summary: The FDA Form 483 inspection revealed multiple deficiencies in the facility's quality control, aseptic processing, environmental monitoring, and laboratory controls.

**Quality Control Unit Deficiencies:**
*   The quality control unit lacks responsibility for approving and rejecting procedures or specifications impacting drug product identity, strength, quality, and purity.

**Aseptic Process Simulation Issues:**
*   Missing 60 mL syringe units from aseptic process simulations on 09/20/2018 (Lot #092018LR) and 09/19/2018 (Lot #091918KS) were not incubated or tested for microbial growth.
*   Syringes used for equipment priming and calibration during these simulations were also not incubated or tested. No explanation was documented for these omissions.
*   Procedures to prevent microbiological contamination lacked validation of the aseptic process.

**Complaint Handling Deficiencies:**
*   Investigation records for drug complaints lacked findings and follow-up.
*   Complaint 0115 (02/04/2019) regarding particulates in Sodium Bicarbonate syringes (e.g., Lot #30001883) determined crystallization in transit, but the investigation did not include stability/formulation review, retain sample review, or particulate identification.
*   Shipping studies to assess transit conditions' effects on compounded drug products have not been performed

## Related Documents

- [483 - 2017-06-02](https://www.keypedia.com/records/483/quva-pharma-inc/1e39698c-7d20-4ed8-ae3a-29f14b507519)
- [483 - 2019-03-14](https://www.keypedia.com/records/483/quva-pharma-inc/ac997419-c9b0-4f1b-9875-97a2b70ddc77)
- [483 - 2017-11-30](https://www.keypedia.com/records/483/quva-pharma-inc/db7a8ffe-e43a-4fef-be20-cac0f6d0f13f)
- [483 - 2019-04-23](https://www.keypedia.com/records/483/quva-pharma-inc/18f5b923-5e6c-4138-ae7b-8b6483eaa65e)
- [483 - 2022-08-18](https://www.keypedia.com/records/483/quva-pharma-inc/59535d99-826d-4405-be15-8b10bb5cde4f)

## Related Officers

- [Investigator](https://www.keypedia.com/people/guerlain-ulysse/aeef6f71-43b1-4116-b563-8bb3f2966d6a)

Company: https://www.keypedia.com/companies/quva-pharma-inc/1852735f-efbc-4896-9ba0-465f07d479e6

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248