# FDA 483 - Exact Medical Manufacturing, Inc. - March 11, 2021

Source: https://www.globalkeysolutions.net/records/483/exact-medical-manufacturing-inc/44c2f0e3-dff1-400c-9731-88912c0e004f

> FDA 483 for Exact Medical Manufacturing, Inc. on March 11, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Exact Medical Manufacturing, Inc.
- Inspection Date: 2021-03-11
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Exact Medical Manufacturing, Inc. in Lancaster, NY, was inspected regarding its medical device manufacturing processes. The inspection revealed significant deficiencies in design controls, specifically concerning design validation and documentation of design input requirements for ultrasound transducer/probe covers. Additionally, the firm's corrective and preventive action procedures were found to be inadequate, a repeat observation from a previous inspection.

## Related Documents

- [483 - 2017-11-21](https://www.globalkeysolutions.net/records/483/exact-medical-manufacturing-inc/a218c050-2dc9-4d1c-8a36-a89608eabd8c)

## Related Officers

- [Matthew D. Schnittker](https://www.globalkeysolutions.net/people/matthew-d-schnittker/cf76f07f-db6d-47a0-8412-7eb084d4fe8b)

Company: https://www.globalkeysolutions.net/companies/exact-medical-manufacturing-inc/3c92bb56-3cab-4bd5-bf14-c3d5bb0df04e

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961