Union Carbide Corporation a subsidiary of The Dow Chemical Company – FDA EIR, Feb 16, 2011

An FDA inspection of Union Carbide Corp - Subsidiary of Dow Chemical Co in Texas City, TX, was conducted from January 26 to February 16, 2011. The inspection focused on the company's manufacturing of non-sterile Isopropanol (Isopropyl Alcohol, USP), an active pharmaceutical ingredient (API). Initially, the report stated no FDA Form 483 (Inspectional Observations) was issued, and no objectionable conditions were observed across quality, facilities, equipment, production, and laboratory subsystems. However, during the final discussions with management, two key deficiencies were identified. First, the firm did not maintain all initial testing data (such as water determination, GC, UV, and phosphate data) directly with the batch records for commingled batches of Anhydrous IPA. While some data was retrievable from the electronic LIMS system, comprehensive record-keeping was lacking. Second, the company did not possess complete Master Production Instructions, a requirement under ICH Q7 guidelines for API manufacturing. In response, management committed to developing specific procedures for record-keeping at each batch stage and to creating the necessary Master Production Instructions document. The inspection was carried out in accordance with CP 7356.002F for API process inspections.