The FDA has warned Lee Laboratories for several current good manufacturing practice (cGMP) violations, most of which were repeat violations from a previous agency inspection.
During agency inspections last fall, the FDA found that Lee’s extraoral orthodontic headgear was adulterated because of cGMP violations, according to a letter that was posted to the FDA Web site on January 16.
Lee’s office manager said the company would not correct the inspectional observations because the firm was closing its business in 60 days, the letter noted. However, the FDA has not received a confirmation of the closing.
