FDA EIR - Granules Pharmaceuticals Inc. - January 28, 2022

An FDA pre-approval inspection of Granules Pharmaceuticals Inc. in Chantilly, VA, was conducted from January 24-28, 2022. The inspection, guided by Compliance Program 7346.832 for Pre-Approval Inspections/Investigations, focused on the manufacturing of Butalbital/Acetaminophen/Caffeine Tablets, USP, and Methocarbamol Tablets, USP. The purpose was to assess the firm's readiness for commercial production, application conformance, and data integrity for these two prescription oral dosage drug products.

During the inspection, the FDA issued a three-item Form FDA 483, highlighting key issues. These included failures to consistently follow written production and process control procedures, inadequate record-keeping for equipment cleaning and sanitization, and a lack of established and followed written procedures for cleaning and maintaining equipment and utensils. Additionally, a verbal observation noted that the warehouse temperature and humidity monitoring Standard Operating Procedure (SOP) did not specify its review status.

This inspection followed a previous pre-approval inspection in June 2021, which had a "voluntary action indicated" classification. Granules Pharmaceuticals Inc. committed to providing a voluntary written response to the latest observations within 15 business days. Despite the identified issues, an approval recommendation was submitted for both drug products under review.