# FDA 483 - Exact Medical Manufacturing, Inc. - November 21, 2017

Source: https://www.globalkeysolutions.net/records/483/exact-medical-manufacturing-inc/a218c050-2dc9-4d1c-8a36-a89608eabd8c

> FDA 483 for Exact Medical Manufacturing, Inc. on November 21, 2017. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Exact Medical Manufacturing, Inc.
- Inspection Date: 2017-11-21
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Exact Medical Manufacturing, Inc. in Lancaster, NY, a medical device specification developer, identified three significant issues related to their quality system. The firm was cited for inadequate procedures for training, deficiencies in their corrective and preventive action (CAPA) system, and a lack of approval signatures on critical documents. These observations indicate a need for improved adherence to quality system regulations.

## Related Documents

- [483 - 2021-03-11](https://www.globalkeysolutions.net/records/483/exact-medical-manufacturing-inc/44c2f0e3-dff1-400c-9731-88912c0e004f)

## Related Officers

- [Joel R Powers](https://www.globalkeysolutions.net/people/joel-r-powers/b1c3a33f-1337-45ee-845a-e90688b8875a)
- [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