# FDA 483 - Nelson Laboratories Fairfield, Inc. - November 20, 2019

Source: https://www.keypedia.com/records/483/nelson-laboratories-fairfield-inc/be66f915-4c2e-43d1-a7ea-923ae59335d3

> FDA 483 for Nelson Laboratories Fairfield, Inc. on November 20, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Nelson Laboratories Fairfield, Inc.
- Inspection Date: 2019-11-20
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Gibraltar Laboratories, Inc. in Fairfield, NJ, a control laboratory testing facility, revealed significant deficiencies in laboratory control mechanisms. Observations included the use of uncontrolled personal notebooks for recording GMP data, a failure to conduct out-of-specification investigations for purified water, and incomplete laboratory records lacking essential raw data for bacterial endotoxin testing.

## Related Documents

- [483 - 2019-01-07](https://www.keypedia.com/records/483/nelson-laboratories-fairfield-inc/d2c84123-2832-4119-afa6-d4d868e34a00)
- [483 - 2023-04-05](https://www.keypedia.com/records/483/nelson-laboratories-fairfield-inc/052245f2-a3e2-4d0f-8951-26603682811c)

## Related Officers

- [investigator](https://www.keypedia.com/people/monika-borkowska/4dedee7d-7b93-4f1b-be3b-17ab41e5c0ff)
- [Vvesna C Blaise](https://www.keypedia.com/people/vvesna-c-blaise/fe5a2321-1072-48f1-ba45-7afda6352a0a)

Company: https://www.keypedia.com/companies/nelson-laboratories-fairfield-inc/8a60e01d-bc82-4e1c-8a26-e9ae7f82475e

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