FDA 483 - Medcraft LLC - July 27, 2018

This FDA Form 483 was issued to Medcraft LLC, an outsourcing facility located at 1312 Commercial Ave., Mounds, OK 74047. The inspection was conducted from May 14, 2018, to July 27, 2018, and the report was issued on July 27, 2018, to John C. Davidson, Quality Director.

The sole observation noted was a deficiency in the aseptic processing areas concerning the system for cleaning and disinfecting the room and equipment to produce aseptic conditions. Specifically, Medcraft LLC is not adhering to the required contact (dwell) times specified in their procedure SOP-013, "Cleaning and Disinfection of the Facility," version 3, effective January 11, 2017. This procedure mandates following the disinfectant manufacturer's recommended contact times. The labeling for the sporicide requires a [redacted] minute contact time, and the disinfectant requires a [redacted] minute contact time. The firm's Pharmacist stated that the solution is sprayed onto a sterile wipe and then used to wipe down the surface of the ISO 5 hood, which does not maintain wetness for the required [redacted] or [redacted] minutes.