FDA 483 - Med Shop Total Care Inc. - July 27, 2021

An FDA inspection conducted at Med Shop Total Care Inc. from July 7 to July 27, 2021, identified significant deficiencies in its sterile and non-sterile drug manufacturing operations. The inspection, carried out under the Federal Food, Drug and Cosmetic Act, revealed several critical issues pertaining to current Good Manufacturing Practices (cGMP).

Key violations included a repeated failure to adequately investigate and take remedial action for microbial contamination found in the ISO 5 aseptic processing area, where the company continued to produce and distribute sterile products despite environmental monitoring findings. The facility's design also allowed for the ingress of poor-quality air into cleaner areas, exemplified by the lack of recertification after HVAC system replacement and unsealed doors between classified spaces. Inspectors also noted non-microbial contamination on HEPA filter screens and insufficient disinfectant contact times during cleaning procedures.

Furthermore, personnel were observed compromising aseptic technique by touching non-sterile surfaces with gloved hands before engaging in aseptic processing without proper glove changes or sanitization. Media fill simulations, a crucial measure of aseptic process effectiveness, were found to be inadequate, failing to incorporate worst-case scenarios and performed infrequently for some operations – a repeat observation. Finally, the firm released drug products that did not meet quality standards, specifically a recalled lot of Bupivacaine due to sterility failure. Med Shop Total Care Inc. is expected to implement prompt and comprehensive corrective actions to resolve these serious findings and ensure compliance with regulatory requirements for drug quality and patient safety.