FDA 483 - QuVa Pharma, Inc. - April 20, 2018

An FDA inspection of QuVa Pharma, Inc., an outsourcing facility in Temple, TX, conducted from April 16-20, 2018, revealed significant deficiencies in its manufacturing practices. The firm's quality control unit was found to lack adequate authority and execution, failing to fully investigate anomalous data in sterility testing where negative controls showed unexpected results, yet corresponding human drug products were released as sterile. Additionally, persistent negative pressure excursions in an ISO 7 cleanroom, indicating a risk of contamination from unclassified areas, remained unaddressed for twelve months without investigation.

The inspection also highlighted incomplete investigations into drug complaints for products like Neostigmine and Rocmonium PF, with records lacking full findings or essential manufacturing details. The company was cited for not having sufficient written procedures and supporting data to validate sterilization processes for bulk drug products, resulting in the release of products sterilized through an unvalidated process. Furthermore, the facility's design incorporated pass-through boxes that created unclassified communication routes into ISO 7 cleanrooms, compromising aseptic conditions for sterile injectable products. QuVa Pharma, Inc. is required to implement comprehensive corrective and preventive actions to resolve these critical issues and ensure compliance with regulatory standards for drug quality and patient safety.