# FDA WARNING_LETTER - QuVa Pharma, Inc. - October 14, 2022

Source: https://www.keypedia.com/records/warning_letter/quva-pharma-inc/4dfc2843-4da2-4f5c-a7d2-ac6b7365a71e

> FDA WARNING_LETTER for QuVa Pharma, Inc. on October 14, 2022. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: QuVa Pharma, Inc.
- Inspection Date: 2022-10-14
- Product Type: Drugs
- Office Name: Division of Pharmaceutical Quality Operations I
- Summary: The FDA issued a Warning Letter to QuVa Pharma, Inc. (Bloomsbury, NJ) following an inspection from August 16 to October 14, 2022. The facility, registered as an outsourcing facility under FDCA section 503B, was found to have serious deficiencies in producing sterile drug products, rendering them adulterated under sections 501(a)(2)(A) (insanitary conditions) and 501(a)(2)(B) (CGMP violations) of the FDCA.

Specific deficiencies included inadequate microbial recovery action levels in ISO 5 areas, where any contamination should trigger immediate assessment of drug products. The company's updated SOP allowed for a (b)(4) CFU action level, which the FDA deemed insufficient. Additionally, investigations into incidents like ISO 5 hood pressure issues and suspected drug splash were found to be lacking or unclear, with insufficient documentation and discrepancies between reports.

The FDA acknowledged QuVa Pharma's voluntary recall of oxytocin 30 Units/500 mL (Lot # 30027403) due to incorrect formulation on September 20, 2022. While some corrective actions were noted, many lacked adequate supporting documentation or were deemed deficient. The FDA strongly recommended a comprehensive assessment of operations, including aseptic processing, with assistance from a third-party consultant. Failure to address these violations promptly may result in legal action

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## Related Officers

- [Program Division Director](https://www.keypedia.com/people/lisa-m-harlan/e5d04349-6dd6-4f08-b31f-bf719c8413ab)

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

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-i/6ded4818-ee3a-46a1-84c1-36de58502b02