# FDA 483 - New England Ortho Laboratory, Inc. - February 18, 2022

Source: https://www.keypedia.com/records/483/new-england-ortho-laboratory-inc/97c7e608-11a7-41ab-823b-75a383bb876c

> FDA 483 for New England Ortho Laboratory, Inc. on February 18, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: New England Ortho Laboratory, Inc.
- Inspection Date: 2022-02-18
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: New England Ortho Laboratory, Inc. in Andover, MA, a manufacturer of medical devices, was cited for several deficiencies during an FDA inspection. Observations included inadequate documentation of device history records, lack of documented equipment maintenance, and failure to perform and document quality audits and management reviews. These issues indicate a lack of adherence to established quality system procedures.

## Related Officers

- [Nabil Nakhoul](https://www.keypedia.com/people/nabil-nakhoul/d676e9c9-566c-4e59-84e8-1dc474e4e48d)

Company: https://www.keypedia.com/companies/new-england-ortho-laboratory-inc/3ce29c39-fb55-44ed-938e-b15d4a288759

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