# FDA 483 - Boston Analytical, Inc. - January 24, 2020

Source: https://www.keypedia.com/records/483/boston-analytical-inc/07877e66-680b-4933-9233-62a5b80ef946

> FDA 483 for Boston Analytical, Inc. on January 24, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Boston Analytical, Inc.
- Inspection Date: 2020-01-24
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: Boston Analytical, Inc., a control testing laboratory in Salem, NH, was cited for failing to follow written procedures for sampling and testing drug products. The microbiology laboratory repeatedly failed to adequately follow microbial enumeration test methods, as evidenced by numerous instances of positive growth on negative controls. These failures were not reported to clients, indicating a significant breakdown in quality control and data integrity.

## Related Documents

- [483 - 2012-11-09](https://www.keypedia.com/records/483/boston-analytical-inc/53642e2a-eb7c-47d7-b46c-68d89265485f)

## Related Officers

- [Robert J. Martin](https://www.keypedia.com/people/robert-j-martin/8bd5c75a-ec53-4ae5-9739-a39489686cae)

Company: https://www.keypedia.com/companies/boston-analytical-inc/a21fce05-8b60-4a91-ac00-217015ac046a

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94