PQ Corporation – FDA EIR, Feb 22, 2022

An FDA inspection of PQ Corporation's Active Pharmaceutical Ingredient (API) manufacturing facility in Utica, IL, took place from February 15-22, 2022. This pre-announced inspection, part of the FY22 work plan, was conducted under compliance programs for API and animal drug manufacturing, specifically reviewing operations for Magnesium Sulfate Heptahydrate, USP (Epsom Salt). The inspection culminated in the issuance of a six-item Form FDA-483, highlighting critical deficiencies. The primary issues included a lack of an independent quality unit, resulting in analysts reviewing their own work and investigations being incomplete or significantly delayed, some taking almost two years to close. A recurring observation was the firm's failure to maintain complete batch records, missing crucial information such as raw material batch numbers and verification signatures for critical steps. Facility maintenance was also inadequate, with multiple insanitary conditions, including pervasive spider webs and a leaking ceiling in the in-process testing lab. Control over the issuance of manufacturing documents was deficient, lacking proper revision histories and unrestricted access to master records. Additionally, the company had no written procedures or scientific rationale for water handling and sampling, despite water being a component in their product. Lastly, computerized systems, particularly the software used for managing CAPAs, change controls, and complaints, were found to be unvalidated for their GMP activities. PQ Corporation committed to submitting a written response to these observations within 15 business days, outlining their corrective actions.