# FDA 483 - Grant Industries,  Inc. - August 21, 2020

Source: https://www.keypedia.com/records/483/grant-industries-inc/7ba368ed-894b-484e-8ad5-c4ea2a66fc33

> FDA 483 for Grant Industries,  Inc. on August 21, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Grant Industries,  Inc.
- Inspection Date: 2020-08-21
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Grant Industries, Inc., an API manufacturer in Elmwood Park, NJ, revealed significant deficiencies in their quality system. Observations included missing personnel training records, failure to follow established quality unit procedures for complaint handling, cleaning validation, and laboratory practices, and inadequate control over computer-related systems. These issues indicate a lack of robust quality oversight and compliance with cGMP requirements.

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## Related Officers

- [Tonia F. Bernard](https://www.keypedia.com/people/tonia-f-bernard/607c8dae-63cb-491a-8d7d-ddfa0ee1b67d)
- [investigator](https://www.keypedia.com/people/anthony-j-donato/a6dd6e14-529e-4b23-9b5f-02c88afb80ae)

Company: https://www.keypedia.com/companies/grant-industries-inc/bf60053c-0aa3-4217-b068-ef8b06b6bd27

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