# FDA 483 - Keystone Industries - November 07, 2025

Source: https://www.keypedia.com/records/483/keystone-industries/48e137e1-74c9-46cc-bf44-164555606b70

> FDA 483 for Keystone Industries on November 07, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Keystone Industries
- Inspection Date: 2025-11-07
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Keystone Industries, a human drug manufacturer in Gibbstown, NJ, was cited for a significant deficiency in drug product component testing. The firm failed to perform required identity testing, including the USP limit test, on incoming high-risk components used in their over-the-counter drug products. This lapse raises concerns about the quality and safety of their manufactured drug products.

## Related Documents

- [483 - 2022-12-21](https://www.keypedia.com/records/483/keystone-industries/999d4595-7f83-4e2a-9fa0-79a8fac23107)

## Related Officers

- [Norman K. Starks](https://www.keypedia.com/people/norman-k-starks/4b8776e0-f96e-429c-94d1-40c0369f5378)

Company: https://www.keypedia.com/companies/keystone-industries/7bd50e83-76bc-4765-8075-7abdb6340162

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