# FDA 483 - ONC Solutions Incorporated - September 10, 2019

Source: https://www.keypedia.com/records/483/onc-solutions-incorporated/f7fcdef9-127e-4867-997f-ff70db998188

> FDA 483 for ONC Solutions Incorporated on September 10, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ONC Solutions Incorporated
- Inspection Date: 2019-09-10
- Product Type: device
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: ONC Solutions Incorporated, a medical device manufacturer in Acton, MA, received a Form 483 with four observations during an FDA inspection. The inspection revealed significant deficiencies in the firm's quality system, including inadequate controls for purchased products, environmental conditions, internal audits, and non-conforming materials. Two of the observations, concerning purchased product control and non-conforming material, were repeats from a previous inspection, highlighting persistent issues with the X-Mark Fiducial Marker, a Class II medical device.

## Related Officers

- [Sara M. Onyango](https://www.keypedia.com/people/sara-m-onyango/643c6ad3-9747-4bc2-9e8e-72f97b11e659)

Company: https://www.keypedia.com/companies/onc-solutions-incorporated/41c9522f-b3b5-4395-a7b4-f2177188ffc3

Office: https://www.keypedia.com/offices/fda-district-office-stoneham-massachusetts/880e6c44-d8c6-449f-be9e-c459a23205d1