Peroxychem LLC – FDA EIR, Sep 6, 2017

An FDA inspection of PeroxyChem, LLC in Pasadena, TX, conducted from August 21-24 and September 6, 2017, identified significant deficiencies related to the manufacturing of Active Pharmaceutical Ingredients (API). The unannounced inspection, categorized as a Drug Inspection/Methods Validation, focused on the firm's production of 50% API grade hydrogen peroxide, operating under the cGMP framework for API manufacturers. Four main observations were noted on Form FDA-483. First, the company failed to adequately validate its API batch process, specifically by not justifying the use of multiple batch tanks during validation or validating each tank separately. Second, critical API production equipment, including specific batch mixing tanks, was not adequately qualified prior to process validation activities. Third, there was a lack of established written procedures for cleaning the drum fill station, which was used for both API and non-API products without proper cleaning validation to prevent cross-contamination. Finally, the firm's written procedures for manufacturing intermediates and APIs were not adequately prepared, reviewed, approved, and distributed, evidenced by uncontrolled tank status tags and an unapproved outbound shipping certification form. PeroxyChem’s management committed to addressing these issues. Required actions include undertaking retrospective validation and qualification of equipment and processes, developing a comprehensive cleaning procedure for the drum fill station, and revising document control processes for all relevant manufacturing records and forms. These corrective actions will be reviewed during subsequent FDA inspections.