Barton Carey Medical Products 4/3/96
our Investigator determined that your firm manufactures vascular and burn compression garments. These garments are devices as defined by Section 201(h) of the Federal Food, Drug and Cosmetic Act (the Act). The Inspection revealed that your devices are adulterated in that, the methods used in, or the facilities or controls used for manufacturing, packaging, storage, or installation are not in conformance with the Good Manufacturing Practice Regulations (GMP) for Medical Devices specified in Title 21, Code of Federal Regulations (CFR), Part 820, as follows:
The computer system used to transcribe patients’ prescriptions into the proper measurement and counter- pressure for the cutting of the garments has not been validated. The software presently used is $$$ Version $$$. There have been approximately 15 software changes/upgrades to the commuter software system since your firm first started using it in January 1994. There were no validation studies conducted to evaluate how the changes to the software impact on the computerized system.
