Hunter Holmes McGuire Veterans Affairs Medical Center Mammography – FDA 483, Jul 19, 2018

This FDA Form 483 was issued on July 19, 2018, to the Hunter Holmes McGuire Veterans Affairs Medical Center in Richmond, VA, following an inspection conducted from July 10-13 and July 19, 2018. The facility, FEI number 3003432602, is identified as a producer of sterile drug products.

The sole observation noted was a deficiency in environmental sampling conducted in the production area. Specifically, after low-mounted return air vents were installed in the 5th-floor ISO 7 anteroom and the area was recertified on May 28, 2018, no viable air or viable surface sampling, nor smoke studies, were performed as part of this cleanroom recertification. Furthermore, sterile drug products were produced in the ISO 5 laminar flow hood, located in the ISO 7 anteroom, from May 29, 2018, to July 10, 2018, despite the incomplete recertification. The observation indicates a lapse in environmental monitoring and quality control procedures for sterile drug manufacturing.