Missouri Devicemaker Cited for Cleaning Procedures
The FDA hit Hampton Medical Devices with a Form 483 after discovering shoddy procedures for preventing contamination at its Festus, Missouri facility.
In a Nov. 27-Dec. 3, 2018 inspection, the agency found that the device manufacturer failed to verify the sterilization process for its trephine blade products. It also failed to measure the bioburden in its cleanroom and production area, risking contamination of the blades.
The agency’s investigator found that the facility had no specifications or procedures established for cleanroom monitoring.