Good manufacturing practices lapses related to documentation and validation resulted in a seven-item Form 483 for Environmental Tectonics following an inspection of its Southampton, Pennsylvania facility. The company manufactures industrial sterilizers and test chambers.
FDA investigators observed service reports that represented medical device reportable events that were not processed as complaints. For example, one service report documented a broken handle on a hyperbaric chamber in which a patient was locked for about 20 minutes. A user facility adverse event was filed with the FDA, but no information was available in the service report concerning the medical impact on the patient, the agency said.
In addition, the service report log noted that a previous complaint describing a patient locked inside a hyperbaric chamber was documented about six months earlier.