FDA 483 - Garonit Pharmaceutical, Inc. - October 20, 2020

Lab Express, Inc., an API manufacturer in Fairfield, NJ, received two observations during an FDA inspection in January 2020. The inspection revealed significant deficiencies in the firm's quality unit, specifically regarding the failure to extend investigations into out-of-specification and stability failures for Chlorhexidine Gluconate 20% API. Additionally, the firm lacked adequate laboratory controls and data integrity for their FTIR system, allowing unrestricted access and the potential for data manipulation without audit trails.