QuVa Pharma, Inc. – FDA EIR, Jun 16, 2022

An FDA inspection of QuVa Pharma, Inc.'s Temple, TX facility, a 503B Outsourcing Facility, was conducted from June 7 to June 16, 2022. The inspection assessed the facility's conformance with minimum standards for producing compounded sterile products, evaluated compliance with certain Section 503B requirements under the Federal Food, Drug, and Cosmetic Act (FDCA), and followed up on previous deficiencies.

At the conclusion, the firm was issued a 4-item Form FDA 483, detailing main violations. These included inadequate maintenance of cleanroom floors, specifically observing a hole and cracks in an ISO 7 cleanroom. The inspection also identified a failure to ensure the accuracy of online software used to determine Beyond Use Dates (BUD), insufficient documented instructions within batch records for packaging light-sensitive non-sterile bulk concentrates, and inadequate labeling of non-sterile drug products as required by Section 503B(a)(10)(A).

QuVa Pharma's management committed to submitting a written response to the FDA 483 observations within 15 business days, outlining their corrective actions. They also stated their intention to review and revise their incident reporting and escalation procedures to enhance consideration of potential risks to drug product quality and patient safety.