FDA 483 - Gram Laboratories Inc - April 08, 2025

Gram Laboratories Inc, a contract testing laboratory in Irvine, CA, was cited for three observations during an FDA inspection from April 2-8, 2025. The inspection revealed deficiencies including inadequate investigations into system suitability failures, unqualified equipment and insufficient monitoring of water systems, and a lack of required cGMP training for employees. These issues indicate potential risks to data integrity and product quality.