FDA 483 - Rx Compounding Inc. - August 19, 2016

On August 19, 2016, the FDA issued a Form 483 to Nora Apothecary dba Rx Compounding, LLC, a producer of sterile drug products located in Indianapolis, IN, following an inspection conducted from August 8-12, 16, and 19, 2016. The report was issued to Anthony S. Kantzavelos, Pharm.D (Owner).

The inspection revealed eight observations:

1. **Inadequate Disinfection of Materials:** Equipment and materials were not adequately disinfected prior to entering aseptic processing areas. An operator was observed spraying disinfectant, but it did not contact all surfaces before items were placed in the transfer chamber during compounding of Vancomycin 25mg/ml and Tobramycin 14mg/ml. 2. **Aseptic Manipulation Issues:** Personnel blocked first-pass air movement around open units. An operator passed hands over open sterile ophthalmic bottles during compounding of Vancomycin 25mg/ml and Tobramycin 14mg/ml. 3. **Non-Sterile Gloves:** Personnel engaged in aseptic processing wore non-sterile nitrile gloves that were not sanitized with sterile solution until after exposure to the ISO 5 environment. Gloves were also not form-fitting, with visible creases. 4. **Unclassified ISO 5 Area:** The ISO 5 classified area was located within a non-