QuVa Pharma, Inc.
FDA issued a warning letter to QuVa Pharma, Inc., a 503B outsourcing facility in Bloomsbury, NJ, following an August–October 2022 inspection that revealed serious sterility and CGMP deficiencies in the production of sterile drug products. Investigators observed mold recovery on operator glove finger plate samples in ISO 5 areas, improper aseptic technique by operators, and multiple CGMP violations including inadequate environmental monitoring, failure to investigate batch discrepancies, and inadequate computer system controls. The facility had already initiated a voluntary recall of oxytocin product due to incorrect formulation, and FDA warned that failure to adequately address violations may result in seizure and injunction.
Required actions (2)
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to address any violations.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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