FDA EIR - Grant Industries, Inc. - August 21, 2020

An FDA cGMP inspection of Grant Industries, Inc., a manufacturer of active pharmaceutical ingredients (zinc oxide and titanium dioxide) and cosmetic bulk products in Elmwood Park, NJ, occurred from August 17 to August 21, 2020. The inspection, conducted under Compliance Program 7356.002F for Active Pharmaceutical Ingredient Process Inspection, also served as a follow-up to previous records requests.

The inspection identified three primary violations documented in an FDA-483. First, the company lacked adequate documentation for personnel training, with missing cGMP training records for production and quality control personnel from 2017-2019, and no documented on-the-job training for a Quality Control Technician. Second, the Quality Unit did not fully adhere to its established procedures, including failing to assign unique control numbers to product complaints, not archiving complaint files, deviating from validated kettle cleaning methods, and maintaining laboratory worksheets without proper review signatures or test identification. Third, there was insufficient control over computer systems, notably an unvalidated, non-password-protected Excel worksheet used for critical calculations that was not independently reviewed. Mr. Paul Granatell, Executive Director of Quality, committed to submitting a written response addressing these observations to the Agency within 15 business days.