DENTAL DEVICE COMPANY LACKS SUFFICIENT QUALITY STANDARDS
Thermoplastic Comfort Systems' dental repair devices are adulterated due to violations of current good manufacturing practice requirements, a recent FDA warning letter said.
The Sept. 21 warning letter, posted to the FDA's website Oct. 10, cited the firm for 14 infractions found during an inspection conducted Aug. 8 to 14.
Most of the violations were related to the firm's lack of a system to regulate or define quality. "There is no documentation describing any quality planning activities conducted or how the requirements for quality will be met," the letter said.
The firm's president said she was responsible for quality system requirements "even though she also acknowledged she was unfamiliar with the FDA's quality system regulations," the warning letter noted.