FDA EIR - Chemisphere Corporation - March 17, 2020

A concise Good Manufacturing Practice (GMP) inspection of Chemisphere Corp, an Over-The-Counter (OTC) drug manufacturer in Saint Louis, MO, was conducted by the FDA on March 16-17, 2020. The inspection, performed under CPG 7365.002H for Drug Process Inspections, identified two main deficiencies documented on Form FDA 483. The first observation cited a lack of appropriate controls over computer systems. Specifically, multiple employees could alter dates and times within analytical software, a delete function was available without an active audit trail, and there was no system for unique user identification. Additionally, raw data was found recorded on Post-It Notes in the laboratory. The second observation concerned deficient complaint records. The company's policy required investigations for all complaints, yet investigations were not documented for certain complaint types, and the reasons for not investigating, along with the responsible individuals, were not recorded. Furthermore, during a verbal discussion, the FDA noted that the warehouse's quarantine area was uncontrolled, with released products mixed alongside quarantined materials. Management, including President Matthew R. Schwent, acknowledged these issues and committed to implementing corrective actions. They proposed eliminating post-it notes immediately, addressing computer system controls within six months, and rectifying complaint record deficiencies within two months. The firm was reminded of its responsibilities under the Federal Food, Drug, and Cosmetic Act.