# FDA 483 - Sarstedt Inc - July 02, 2018

Source: https://www.globalkeysolutions.net/records/483/sarstedt-inc/10b46792-dc6d-4b93-9018-15dd456127b3

> FDA 483 for Sarstedt Inc on July 02, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sarstedt Inc
- Inspection Date: 2018-07-02
- Product Type: device
- Office Name: Atlanta District Office
- Summary: Sarstedt Inc. in Newton, NC, a medical device manufacturer, received five observations during an FDA inspection. The firm was cited for inadequate documentation of labels in device history records, insufficient change control procedures, and failures in corrective and preventive action processes. These issues collectively indicate a lack of adherence to established quality system regulations for medical device manufacturing.

## Related Documents

- [EIR - 2018-07-02](https://www.globalkeysolutions.net/records/eir/sarstedt-inc/3055d5f3-0b97-4079-86ef-ccd89ae2b002)

## Related Officers

- [Gamal A. Norton](https://www.globalkeysolutions.net/people/gamal-a-norton/6b52c9e6-d579-4994-81ee-e734eb1f0a67)

Company: https://www.globalkeysolutions.net/companies/sarstedt-inc/f4ac9de6-987b-495b-a99e-5dddb8263e3f

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7