FDA 483 - Medaus, Inc. - March 22, 2013

The FDA Form 483 details multiple deficiencies observed during an inspection of a facility producing injectable drug products, including Betamethasone Acet/NAPO4, Dexamethasone LA 8 mg/mL, and Triamcinolone Acet 60 mg/mL Inj Susp, all made from non-sterile components.

Key violations include: 1. **Inadequate Sterilization Process Validation:** The firm lacks equipment qualification for the sterilization method used for specific finished products and has not performed validation for the method used for all injectable solution drug products from non-sterile components. 2. **Insufficient Protective Apparel:** Personnel in the ISO-7 cleanroom producing injectables did not wear apparel covering all skin on the forehead, around the eyes, and neck. Hoods and goggles were absent, and worn items (hairnets, beard covers, face masks, disposable lab coats) were non-sterile. 3. **Deficient Media-Fill Process:** The media-fill procedure does not adequately simulate aseptic processing steps for injectable drug products. 4. **Inadequate Environmental Monitoring:** The environmental monitoring program for ISO-5 hoods and ISO-7 cleanrooms uses insufficient frequency (redacted intervals under static conditions) for viable/non-viable particulates and surface bioburden. Glove fingertip bioburden monitoring is also performed at inadequate redacted intervals. 5. **Aseptic Area Air Supply Deficiencies:** No monitoring of air pressure differential between the ISO-7