FDA 483 - LGM Pharma, LLC - April 14, 2022

An FDA inspection of LGM Pharma, LLC, conducted between March 15 and April 14, 2022, revealed significant deficiencies in the company's quality management system. The inspection, documented in an FDA Form 483, highlighted a failure to adhere to established internal procedures and adequately control vendor qualifications for active pharmaceutical ingredients (APIs).

A primary concern was the company's inconsistent application of its vendor qualification process. The firm's quality unit did not always utilize the required Vendor Approval and Status Change Form, leading to insufficient documentation regarding vendor statuses. Critically, LGM Pharma continued to use 14 vendors that had been classified as "disqualified" to supply APIs to various customers, including pharmacies and manufacturers, over a period from late 2018 to early 2022, without adequate records explaining their status at the time of shipment.

Furthermore, an investigation into a product shipment that occurred after an FDA product release rescission lacked a proper root cause analysis, risk assessment, or impact evaluation, demonstrating a flaw in deviation management. The company's vendor qualification questionnaires were also found inadequate, failing to require comprehensive reviews of supplier compliance histories, regulatory reports, or crucial quality-related procedures such as recall processes.

Another observation pointed to the firm's vendor qualification standard operating procedure, which lacked a defined method for ensuring that imported and distributed drug substances consistently meet necessary product specifications. These observations indicate a need for LGM Pharma to implement robust corrective and preventive actions to enhance its quality system, ensure strict adherence to its own documented procedures, and strengthen its oversight of vendor qualification and product quality for regulatory compliance.