# FDA 483 - Nelson Laboratories Fairfield, Inc. - January 07, 2019

Source: https://www.keypedia.com/records/483/nelson-laboratories-fairfield-inc/d2c84123-2832-4119-afa6-d4d868e34a00

> FDA 483 for Nelson Laboratories Fairfield, Inc. on January 07, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nelson Laboratories Fairfield, Inc.
- Inspection Date: 2019-01-07
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Gibraltar Laboratories, Inc., a control test laboratory in Fairfield, NJ, revealed a critical lapse in laboratory control systems. Specifically, a microbiologist pre-documented analytical results for USP<62> suitability testing without actually performing the test or allowing for proper incubation. This serious data integrity issue was only uncovered following a customer complaint.

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## Related Officers

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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