# FDA 483 - Custom Assemblies, Inc. - October 06, 2022

Source: https://www.globalkeysolutions.net/records/483/custom-assemblies-inc/1b9e71f9-f67b-4257-87f2-2621ceb0aee7

> FDA 483 for Custom Assemblies, Inc. on October 06, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Custom Assemblies, Inc.
- Inspection Date: 2022-10-06
- Product Type: device
- Office Name: Atlanta District Office
- Summary: Custom Assemblies, Inc. in Pine Level, NC, a manufacturer of Class II medical devices, was cited for significant deficiencies in its document control procedures and record-keeping practices. The inspection revealed issues such as missing approval forms, outdated documents, incomplete logs, and blank data sections in critical quality system records. These findings indicate a lack of adherence to the firm's own established procedures for maintaining records.

## Related Documents

- [483 - 2017-07-31](https://www.globalkeysolutions.net/records/483/custom-assemblies-inc/0ded2461-6ef3-48f5-8f73-3fc1e78c40d7)
- [483 - 2019-07-19](https://www.globalkeysolutions.net/records/483/custom-assemblies-inc/06309fd1-512f-41e9-a8cf-d922efe88170)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/inga-m-warr/f27805b8-c2ba-4af5-bf5e-ff2e2f511ec1)

Company: https://www.globalkeysolutions.net/companies/custom-assemblies-inc/22d6dc22-42d3-4a2c-93e0-1da2d7a26140

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