# FDA 483 - Consolidated Machine Corp. - November 27, 2019

Source: https://www.globalkeysolutions.net/records/483/consolidated-machine-corp/91948fbc-613b-4009-a98e-44012d9aaee7

> FDA 483 for Consolidated Machine Corp. on November 27, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Consolidated Machine Corp.
- Inspection Date: 2019-11-27
- Product Type: device
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: Consolidated Machine Corp. in Billerica, MA, received a Form FDA 483 with two observations following an inspection. The firm was cited for failing to adequately establish design review procedures and for not performing quality audits at a sufficient frequency. These deficiencies indicate issues with the firm's quality system regarding medical device design control and quality assurance documentation.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/james-p-finn/70e5c36c-2711-449b-bf73-e08b4dd58449)

Company: https://www.globalkeysolutions.net/companies/consolidated-machine-corp/fb78a13c-d4da-4a50-91af-2bad57f41db7

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7