FDA 483 - Med Shop Total Care Inc. - June 08, 2023

An FDA inspection of Med Shop Total Care Inc., a producer of sterile and non-sterile drugs in Longview, TX, was conducted from May 16, 2023, to June 8, 2023. The inspection resulted in the issuance of an FDA Form 483, detailing observations related to the firm's manufacturing processes. The primary concern identified was a failure to perform routine environmental monitoring in classified areas. Specifically, the firm did not monitor a laptop situated adjacent to a Laminar Flow Hood (ISO5), which was frequently touched by sterile compounding technicians during the production of sterile human drug products. Examples included the manufacture of Hydromorphone HCl PF 4MG/ML Injectable and Morphine Sulfate-Baclofen PF 10/MG/100MCG, where the laptop was used to enter data between filling sterile syringes. This practice raises concerns about potential product contamination and falls under the provisions of Section 704(b) of the Federal Food, Drug and Cosmetic Act. Med Shop Total Care Inc. is expected to address these observations by implementing appropriate corrective actions to ensure compliance and maintain product safety.