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

Source: https://www.keypedia.com/records/eir/benchmark-electronics-inc/25fa40c1-783b-405b-b1c2-030e47abff42

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

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## Details

- Record Type: EIR
- Company Name: Benchmark Electronics, Inc.
- Inspection Date: 2020-08-26
- Product Type: Devices
- Office Name: New England District Office
- Summary: An FDA Level II (Baseline) inspection was conducted at Benchmark Electronics, Inc. in Nashua, NH, from August 24 to August 26, 2020. The inspection reviewed the firm's operations as a contract manufacturer of Class II medical device printed circuit assemblies, focusing on Management Controls, Corrective Actions and Preventive Actions (CAPA), and Production & Process Controls. The regulatory framework for this inspection involves the Quality System Regulation, specifically referencing 21 CFR 820.70(c) concerning environmental controls.

The inspection resulted in one observation on FDA Form 483, indicating that procedures to control environmental conditions were not adequately established. Specifically, the company failed to consistently monitor and maintain required humidity levels on the operational floor, particularly in areas associated with soldering electronic components, and within the clean room. There were documented gaps in environmental monitoring data, and management could not provide non-conformance records or risk assessments regarding the potential impact of these environmental deviations on product quality or patient safety. In response, Benchmark Electronics management acknowledged the deficiency and committed to correcting the issues. The firm's General Manager stated they would provide a written response to the FDA Form 483 within 15 business days, outlining their corrective actions to address the identified environmental control deficiencies.

## Related Documents

- [483 - 2020-08-26](https://www.keypedia.com/records/483/benchmark-electronics-inc/c72cee00-b390-4a7a-902a-1aac63b00ecd)

## Related Officers

- [company_representative](https://www.keypedia.com/people/richard-r-glasheen/3e760d81-0668-4132-aea6-5e214582b79a)
- [Investigator](https://www.keypedia.com/people/stephen-c-smith/426649fa-0e5b-4b35-ba41-636512a06a48)
- [recipient](https://www.keypedia.com/people/gerald-r-leo/c98392d6-642b-4803-b969-1b86136531f7)
- [company_representative](https://www.keypedia.com/people/melissa-o-sturgis/d85b89ac-f778-46c0-930a-4a2425bab24d)

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

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144