483
Wayne County Chapter of NYARCFDA 483 - Wayne County Chapter of NYARC - September 16, 2020
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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.
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ID · 64a7f9da-bbb3-4569-be80-4dd3b753da6e