FDA WARNS ORTHODONTIC DEVICE FIRM FOR REPEAT VIOLATIONS
The FDA warned Lee Laboratories for several current good manufacturing practice (cGMP) violations, most of which were repeat violations from a previous agency inspection. The company, however, said it will not make any changes because it is planning to go out of business.
During agency inspections Sept. 2527, 2006, the FDA found that Lee's extraoral orthodontic headgear was adulterated because of cGMP violations, said the Dec. 26 letter, which was posted to the FDA website Jan. 16.
Lee's office manager responded to the Form 483 Oct. 4, 2006, saying the company would not correct the inspectional observations because the firm was closing its business in 60 days, the letter noted. However, the FDA said it has not received a confirmation of the closing.
The company made few corrections following an agency inspection in August 2004, and most of the violations were repeats from the earlier inspection, the letter said.