Guardian Drug Co. Inc. – FDA EIR, Nov 15, 2019

An FDA inspection of Guardian Drug Co. Inc. in Dayton, NJ, was conducted from October 31 to November 15, 2019. This comprehensive surveillance inspection included Current Good Manufacturing Practice (CGMP) assessments and Pre-Approval Inspections (PAIs) for two Abbreviated New Drug Applications (ANDAs): Omeprazole Sodium Bicarbonate capsules and Loratadine 10 mg tablets. No Form FDA 483, Inspectional Observations, was issued, indicating a generally compliant status.

During the inspection, several issues were discussed with management for voluntary correction. A key concern was the firm's Out-of-Specification (OOS) Standard Operating Procedure, which lacked clarity regarding product rejection after a confirmed OOS retest. The company committed to revising this SOP. Additionally, for ANDA 207569 (Loratadine 10 mg tablets), the originally intended commercial batch size equipment was not on-site and qualified as stated in the application. Guardian Drug Co. Inc. responded by submitting an amendment to the FDA to reduce the proposed commercial batch size and use currently qualified equipment. A third issue, the co-location of primary and backup servers, which posed a data integrity risk, was immediately resolved by relocating the backup server.

The inspection also verified the adequate implementation of voluntary corrective actions for four observations issued during a previous inspection in 2017, covering laboratory records, reagent controls, electronic data security, and post-market approval procedures. Overall, the company demonstrated a commitment to quality and addressed identified areas for improvement.