FDA 483 - Gasco Industrial Corp. - December 08, 2023

Gasco Industrial Corp. in Gurabo, PR, was inspected and received a Form 483 with seven observations, many of which were repeated from a previous inspection, indicating severe and systemic deficiencies. The firm manufactures OTC drug products but exhibits critical failures in contamination prevention, production and process controls, quality control unit responsibilities, product rejection, component identity testing, laboratory controls, and facility maintenance. These issues collectively suggest a significant lack of adherence to Good Manufacturing Practices.