# FDA 483 - Opus KSD, Inc. - November 12, 2021

Source: https://www.globalkeysolutions.net/records/483/opus-ksd-inc/b512ec85-fec8-49e4-b053-1570708e02d7

> FDA 483 for Opus KSD, Inc. on November 12, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Opus KSD, Inc.
- Inspection Date: 2021-11-12
- Product Type: device
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: Opus KSD, Inc. in Pembroke, MA, was inspected from November 10-12, 2021, and received a Form FDA 483 with two observations. The inspection revealed deficiencies in the firm's procedures for complaint handling and adverse event reporting, as well as inadequacies in their design input procedures. These issues indicate a need for improved quality system controls.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/john-a-sciacchitano/9f8f49bf-1971-449e-972e-b516418ea78e)

Company: https://www.globalkeysolutions.net/companies/opus-ksd-inc/a8c6b9ca-5b92-4a2a-b2a8-1a3c9c857320

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