FDA EIR - Stratus Pharmaceuticals Inc - March 08, 2018

An FDA inspection of Stratus Pharmaceuticals Inc. (SPI) was conducted from March 6-8, 2018, primarily to verify compliance with a Consent Decree of Permanent Injunction (17-CV-21659) and Current Good Manufacturing Practices (cGMP). This follow-up inspection aimed to confirm corrections to deficiencies from a previous 2014 inspection regarding complaint handling, quality control unit definition, adverse drug experience reporting, and employee training. All previously cited deficiencies were confirmed as corrected.

During the current inspection, no formal FDA-483 observations were issued; however, several verbal discussion items highlighted areas for improvement. Key issues included the distribution of drug products, specifically Artic Relief 4% pain relieving gel, prior to its approved release, which violated the Consent Decree. The company also lacked written procedures and documentation for warehouse cleaning. Other concerns involved inconsistencies in temperature monitoring procedures, inappropriate data handling practices such as using white-out on raw data sheets, and the absence of a customer response form within their recall procedure to aid in product accountability. Management agreed to address these items, with required actions including establishing written cleaning procedures, improving data integrity, implementing a customer response form for recalls, and ensuring products are only distributed after official release.