# FDA 483 - Bentley Laboratories LLC - August 17, 2022

Source: https://www.keypedia.com/records/483/bentley-laboratories-llc/5701b218-4963-4f93-a32e-294c20c11436

> FDA 483 for Bentley Laboratories LLC on August 17, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bentley Laboratories LLC
- Inspection Date: 2022-08-17
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Bentley Laboratories LLC in Edison, NJ, was cited with three observations during an FDA inspection concerning its manufacturing of OTC drug products. The firm failed to establish adequate control procedures and conduct process validation studies, and its batch production records lacked essential details and personnel identification. Additionally, sampling and testing plans for drug products were not properly described in written procedures.

## Related Officers

- [investigator](https://www.keypedia.com/people/monika-borkowska/4dedee7d-7b93-4f1b-be3b-17ab41e5c0ff)
- [investigator](https://www.keypedia.com/people/anthony-j-donato/a6dd6e14-529e-4b23-9b5f-02c88afb80ae)

Company: https://www.keypedia.com/companies/bentley-laboratories-llc/e7aba57d-429b-4e86-a7cb-fcf29a745ff2

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