FDA 483 - Meditech Laboratories, Inc - March 18, 2016

During an FDA inspection from March 10-18, 2016, Meditech Laboratories, Inc., a producer of sterile drugs in Las Vegas, NV, received a Form FDA 483 detailing significant deficiencies in their manufacturing processes and quality control systems. These observations indicate a failure to adhere to Current Good Manufacturing Practices (cGMP), especially concerning sterile product production.

Key violations included severe deficiencies in aseptic processing areas, such as discolored HEPA filters, uncontrolled humidity, and a prolonged lack of documented environmental monitoring for critical parameters. The company failed to validate analytical methods for potency testing and released a batch without required sterility, potency, or endotoxin tests. Batch records were not fully approved before product release, and inadequate, non-sterile protective apparel was used by operators. Environmental monitoring was insufficient, cleaning and disinfection were poorly documented, and finished product expiration dates were assigned beyond API expiry. Critically, Meditech Laboratories failed to investigate consumer complaints, out-of-specification potency results, or adequately identify environmental isolates, and lacked written procedures for handling complaints and investigations. The firm must implement comprehensive corrective and preventive actions to rectify these systemic issues and ensure product quality and patient safety.