QuVa Pharma, Inc.

Warning LetterOpen

Mr. Stuart Hinchen CEO QuVa Pharma, Inc. 3 Sugar Creek Center Blvd, Suite 250 Sugar Land , TX 77478 United States stuart.hinchen@quvapharma.comFEI 3013931875Issued Jan 26, 2024Division of Pharmaceutical Quality Operations I

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Violations1

Issue DateJan 26, 2024

Product TypeDrugs

StatusOpen

Letter Details

Firm: QuVa Pharma, Inc.
Location: Mr. Stuart Hinchen CEO QuVa Pharma, Inc. 3 Sugar Creek Center Blvd, Suite 250 Sugar Land , TX 77478 United States stuart.hinchen@quvapharma.com
FEI Number: 3013931875
Country: United States
Issue Date: January 26, 2024
Issuing Office: Division of Pharmaceutical Quality Operations I
Product Type: Drugs
Status: Open

Summary

QuVa Pharma, Inc., a registered outsourcing facility, produced sterile drug products with serious deficiencies in manufacturing practices that put patients at risk during an inspection conducted from August to October 2022. The facility's violations included inadequate controls for sterile drug production, which led to the company voluntarily recalling oxytocin 30 Units/500 mL due to incorrect product formulation in September 2022. The FDA determined that QuVa Pharma produced drugs that violated the Federal Food, Drug, and Cosmetic Act by failing to meet the conditions required for outsourcing facility exemptions under Section 503B.

QuVa Pharma, Inc. FDA Warning Letter, January 26, 2024