FDA 483 - Wayne County Chapter of NYARC - September 16, 2020

The FDA inspected Wayne County Chapter of NYARC, a drug repacker in Newark, NY, and issued a Form 483 with six observations. The inspection revealed significant deficiencies across multiple quality system elements, including the absence of a quality control unit, lack of employee training, and inadequate record review. These findings indicate a fundamental lack of adherence to current good manufacturing practices.