# FDA 483 - New Jersey Laboratories - September 22, 2022

Source: https://www.globalkeysolutions.net/records/483/new-jersey-laboratories/b713587b-7449-4ee8-91d3-e8123584384a

> FDA 483 for New Jersey Laboratories on September 22, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: New Jersey Laboratories
- Inspection Date: 2022-09-22
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: New Jersey Laboratories, a control testing laboratory in New Brunswick, NJ, received a Form 483 for deficiencies in their quality unit's investigation procedures. The inspection revealed that investigations into unexplained discrepancies, specifically an Out-of-Specification (OOS) event for residual solvents, were incomplete and lacked proper follow-up, root cause analysis, and corrective actions. This indicates a significant lapse in their quality control processes for handling deviations.

## Related Officers

- [Josh Renzo N. Ramilo](https://www.globalkeysolutions.net/people/josh-renzo-n-ramilo/5b0850ba-e22a-42fc-9310-2beeb921f8f6)
- [Rose L. Jean-Mary](https://www.globalkeysolutions.net/people/rose-l-jean-mary/398483f5-12f7-429b-8a13-c068b41ff3ed)

Company: https://www.globalkeysolutions.net/companies/new-jersey-laboratories/d310e635-49c8-4881-97d4-757fe831e691

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