FDA 483 - Diabetes Corporation of America - August 20, 2015

The FDA issued a Form 483 to Diabetes Corporation of America following an inspection conducted from August 11 to August 20, 2015, at their Franklin, TN facility, a producer of sterile drug products. The inspection revealed significant deficiencies in Good Manufacturing Practices (GMP) relating to the production of sterile drugs. Key observations included a lack of validated sterilization processes for drug product containers and stoppers, and failure to depyrogenate glassware, impacting product sterility. Environmental monitoring in aseptic processing areas was found to be inadequate, with infrequent surface and personnel monitoring, and insufficient viable and non-viable environmental testing. Equipment used to maintain aseptic conditions, such as cleanroom smoke studies and pressure monitoring, was also deemed deficient. Furthermore, the company failed to perform essential laboratory testing for sterility and endotoxins on each batch of drug product. Procedures to prevent microbiological contamination were not properly established or validated, including media fill qualifications and sterilization processes for specific products. Personnel gowning practices were inappropriate, utilizing non-sterile components and lacking complete coverage for aseptic operations. The firm also lacked a written stability testing program for sterile products, leading to unsupported beyond-use dates. Finally, cleaning protocols for aseptic areas did not include sporicides, and time limits for production phases were not established through hold time studies. Diabetes Corporation of America is required to respond to these observations with comprehensive corrective actions to ensure compliance with federal regulations for sterile drug manufacturing.