FDA 483 - Granules Pharmaceuticals Inc. - October 26, 2018

During an inspection conducted from October 22-26, 2018, the FDA identified significant issues at Granules Pharmaceuticals Inc., a drug manufacturer located in Chantilly, VA. The inspection revealed two primary observations indicating non-compliance with drug manufacturing regulations. First, the company failed to ensure that all manufacturing equipment proposed for commercial production of drug products, specifically Methylphenidate HCl ER Capsules and Potassium Chloride ER Tablets, was appropriately designed, installed, and qualified for its intended use. Several critical pieces of equipment, including mixing tanks, blenders, and coaters, were noted as uninstalled and unqualified. Second, deficiencies were found in the firm's laboratory controls. The expiration dating for a critical analytical reagent used in testing various products, including an approved commercial drug, Methylergonovine Maleate Tablets, lacked scientific justification. The company's internal policy for a one-week expiration date for this reagent was not supported by stability data or a reference source, raising concerns about the reliability of analytical testing procedures. Granules Pharmaceuticals Inc. is expected to address these observations with comprehensive corrective actions to ensure regulatory compliance and product quality.