# FDA 483 - Keystone Industries - December 21, 2022

Source: https://www.globalkeysolutions.net/records/483/keystone-industries/999d4595-7f83-4e2a-9fa0-79a8fac23107

> FDA 483 for Keystone Industries on December 21, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Keystone Industries
- Inspection Date: 2022-12-21
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Keystone Industries in Gibbstown, NJ, was cited for two significant issues during an FDA inspection from December 15-21, 2022. The firm failed to perform elemental impurity testing for finished drug product batches and did not follow its own procedures for placing products on stability studies. These deficiencies indicate a lack of adherence to quality control and testing requirements for drug products.

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## Related Officers

- [Investigator ](https://www.globalkeysolutions.net/people/juanita-p-versace/dca6c7fb-62ac-4b06-9c77-dbf52fc83422)
- [Vivin George](https://www.globalkeysolutions.net/people/vivin-george/0b0ee298-a577-4bee-b18e-42da0c3bb148)

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

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