# FDA 483 - Accupac, Llc - November 18, 2021

Source: https://www.globalkeysolutions.net/records/483/accupac-llc/8d9e6eb8-0d74-4945-8860-fa0e5c35d734

> FDA 483 for Accupac, Llc on November 18, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Accupac, Llc
- Inspection Date: 2021-11-18
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Accupac, Llc in Lakewood, NJ was inspected by the FDA from October 21 to November 18, 2021, resulting in two observations. The inspection revealed issues with laboratory documentation practices, where GMP data was recorded on uncontrolled personal notepads, and a failure of the quality control unit to properly qualify a secondary reference supplier for OTC drug products. These findings indicate deficiencies in the firm's adherence to good documentation practices and quality control procedures.

## Related Officers

- [William R. Chang](https://www.globalkeysolutions.net/people/william-r-chang/67893bac-29e2-45b4-ba2c-1ef548781b9c)
- [investigator](https://www.globalkeysolutions.net/people/monika-borkowska/4dedee7d-7b93-4f1b-be3b-17ab41e5c0ff)

Company: https://www.globalkeysolutions.net/companies/accupac-llc/f9c2fbfc-4f22-433c-8e1c-bde11182952f

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248