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

Source: https://www.globalkeysolutions.net/records/483/wayne-county-chapter-of-nyarc/64a7f9da-bbb3-4569-be80-4dd3b753da6e

> FDA 483 for Wayne County Chapter of NYARC on September 16, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Wayne County Chapter of NYARC
- Inspection Date: 2020-09-16
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: 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.

## Related Officers

- [William Leonard](https://www.globalkeysolutions.net/people/william-leonard/1f11ece4-597c-4d3e-aac4-46f8ea404ec3)

Company: https://www.globalkeysolutions.net/companies/wayne-county-chapter-of-nyarc/6bd17956-700c-4bbf-99a1-9f1c4ac6c266

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961