FDA EIR - Eastman Chemical Company - December 01, 2021

An FDA inspection of Eastman Chemical Company in Kingsport, TN, was conducted from November 29 to December 1, 2021. This inspection, performed under Compliance Guidance Program Manual 7356.002F for Active Pharmaceutical Ingredient (API) Process Inspections, focused on the Quality and Laboratory Control System, with limited coverage of Production and Packaging and Labeling for two APIs, including Hydroquinone USP.

The primary deficiency identified, and cited on an FDA Form 483, was that stability testing for Hydroquinone USP was deemed inappropriate to determine product potency. Specifically, Eastman Chemical had eliminated Assay and Impurities testing from its Hydroquinone USP stability program in mid-2020. The remaining tests were found insufficient to determine potency accurately within the product's expiration/retesting period.

Management, represented by Mr. Michael L. Cassell, cGMP Quality Assurance Manager, received the FDA Form 483 and committed to providing a written response within 15 business days. The company was also reminded of its obligation to comply with the Food, Drug, and Cosmetic Act, with potential consequences for non-adherence including regulatory actions such as seizure, injunction, or civil/criminal penalties.