# FDA 483 - Benchmark Electronics, Inc. - August 26, 2020

Source: https://www.keypedia.com/records/483/benchmark-electronics-inc/c72cee00-b390-4a7a-902a-1aac63b00ecd

> FDA 483 for Benchmark Electronics, Inc. on August 26, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Benchmark Electronics, Inc.
- Inspection Date: 2020-08-26
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Benchmark Electronics, Inc. in Nashua, NH, from August 24-26, 2020, revealed inadequate procedures for controlling environmental conditions. Specifically, the firm failed to adequately monitor humidity in operational and cleanroom areas and lacked documentation for non-conformances and product impact assessments related to these issues. This indicates a significant lapse in quality system controls for environmental monitoring.

## Related Documents

- [EIR - 2020-08-26](https://www.keypedia.com/records/eir/benchmark-electronics-inc/25fa40c1-783b-405b-b1c2-030e47abff42)

## Related Officers

- [Investigator](https://www.keypedia.com/people/stephen-c-smith/426649fa-0e5b-4b35-ba41-636512a06a48)

Company: https://www.keypedia.com/companies/benchmark-electronics-inc/f17fc2e6-b16e-4c4a-b684-07cf6a4de56e

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