Rx Compounding Inc. – FDA 483, Aug 19, 2016

On August 8, 9, 10, 11, 12, 16, and 19, 2016, the FDA inspected Rx Compounding Inc., a producer of sterile drug products located at 1101 E. 86th St., Indianapolis, IN 46240. The inspection identified eight observations.

Observation 1 noted inadequate disinfection of equipment and materials entering aseptic processing areas, specifically during Vancomycin and Tobramycin compounding, where sterile spray did not contact all surfaces. Observation 2 cited personnel blocking first-pass air by passing hands over open sterile ophthalmic bottles during aseptic compounding. Observation 3 detailed the use of non-sterile, ill-fitting nitrile gloves by personnel in aseptic processing, which were not sanitized until after exposure to the ISO 5 environment.

Observation 4 indicated the ISO 5 classified area was within a non-classified room, with an uncertified HEPA filter in the anteroom partially covered. Observation 5 stated that chemical sanitizing agents were not used in the cleanrooms, with only a non-chemical method used for the curtained anteroom. Observation 6 found environmental monitoring was not representative of aseptic conditions, citing desiccated and expired agar plates for air testing and test media lacking sanitant neutralizing ingredients for fingertip monitoring.

Observation 7 reported that the certification of the ISO 5 area did not include dynamic conditions for unidirectional airflow studies.