# FDA 483 - J Sterling Industries, LLC - January 08, 2026

Source: https://www.globalkeysolutions.net/records/483/j-sterling-industries-llc/942d8556-440f-4780-950d-9cdcaa1b0746

> FDA 483 for J Sterling Industries, LLC on January 08, 2026. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: J Sterling Industries, LLC
- Inspection Date: 2026-01-08
- Product Type: other
- Office Name: Detroit District Office
- Summary: J Sterling Industries, LLC in Kalamazoo, MI, was cited with three observations during an FDA inspection. The firm demonstrated inadequate control over cleanroom environmental conditions, including issues with specifications, monitoring, and excursion investigations. Furthermore, the company's corrective and preventive action (CAPA) procedures were found to be deficient in initiation, risk assessment, root cause analysis, and effectiveness verification. Lastly, equipment maintenance schedules were not adequately established, and equipment installation did not meet manufacturer requirements.

## Related Officers

- [ Investigator ](https://www.globalkeysolutions.net/people/suyang-qin/c32419c5-1b78-4014-9f94-cb7ab17dfe05)

Company: https://www.globalkeysolutions.net/companies/j-sterling-industries-llc/8b236e5f-b72a-4a39-9ad8-1c4ca4d872dd

Office: https://www.globalkeysolutions.net/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03