# FDA 483 - FAR Specialty Products, Inc. - October 03, 2022

Source: https://www.globalkeysolutions.net/records/483/far-specialty-products-inc/2c884aed-144e-48a8-9097-32289bbcbd5e

> FDA 483 for FAR Specialty Products, Inc. on October 03, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: FAR Specialty Products, Inc.
- Inspection Date: 2022-10-03
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Cyalume Specialty Products Inc., an API manufacturer in Bound Brook, NJ, revealed three significant observations. The firm lacked an effective quality agreement with its contract laboratory for microbial testing, failed to conduct temperature and humidity mapping for a warehouse storing temperature-sensitive materials, and did not have a written procedure for labeling reagents and standard solutions, leading to the use of expired reference standards.

## Related Officers

- [Advisor](https://www.globalkeysolutions.net/people/frederick-razzaghi/7346f6ec-1d9a-4ad3-abde-0497dcd9c8b5)
- [Investigator](https://www.globalkeysolutions.net/people/jay-b-shah/c437fff9-807e-4dea-80c0-8f77850db6f8)

Company: https://www.globalkeysolutions.net/companies/far-specialty-products-inc/4c72d071-0e94-4e7b-b968-b1aca96ea5e0

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