MEDICAL ACTION DEVICE STERILIZATION GMP DEFICIENCIES
This article was originally published in The Gray Sheet
Executive SummaryMEDICAL ACTION DEVICE STERILIZATION GMP DEFICIENCIES outlined by FDA in a Dec. 13 warning letter to the company. The good manufacturing practice violations, FDA says, cause devices manufactured at the company's South Mountain Medical facility, "such as laparotomy sponges, burn dressings, and operating room towels, to be adulterated." The warning letter follows a Sept. 8- Nov. 4 inspection of the company's Asheville, North Carolina-based facility.
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