FDA EIR - Arkema Inc - June 07, 2018

A routine FDA inspection was conducted at Arkema Inc. in Memphis, TN, from June 5 to June 7, 2018. The inspection focused on the domestic active pharmaceutical ingredient (API) manufacturer's quality system and laboratory operations for their bulk hydrogen peroxide API. Significant concerns were identified regarding laboratory data integrity and traceability. Specifically, source data generated by laboratory analyzers and meters lacked specific sample identification, preventing reliable linkage of test results to individual product samples. This deficiency rendered the information on product Certificates of Analysis (CoAs) suspect, as data from batch records could not be verified against original source documents. Additionally, discrepancies were noted in the backup procedures for analytical data from standalone computers, indicating that established backup requirements were not consistently met. These observations were cited under 21 CFR 211.194(a)(1), which mandates that laboratory records include complete sample identification. The objectionable conditions were documented on an FDA-483 form and discussed with company management, who committed to correcting the issues and providing a written response within 15 days.