FDA WARNS LGS FOR PRODUCT TESTING LAPSES
A maker of cooler-heaters received an Aug. 29 warning letter from the FDA for current good manufacturing practice violations in its device testing process. The letter was posted to the agency's website Sept. 12.
The FDA inspected LGS Technologies' facility in Lancaster, Texas, between July 12 and 20 and found the firm's cooler-heaters to be adulterated.
The devices are used to control the water temperature in heat exchangers that warm or cool blood during cardiovascular bypass surgery.
The firm did not establish and maintain adequate procedures for finished device acceptance to ensure that each production run, lot or batch of finished devices met acceptance criteria prior to releasing the devices for distribution, the letter said.
Specifically, LGS failed to follow the required burn-in, or break-in, time and temperature set points for some cooler-heater devices.