# FDA 483 - Carolina Precision Technologies - February 11, 2020

Source: https://www.keypedia.com/records/483/carolina-precision-technologies/e779e799-0347-4e17-a14a-0abf780adb56

> FDA 483 for Carolina Precision Technologies on February 11, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Carolina Precision Technologies
- Inspection Date: 2020-02-11
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Renchel Tool LLC in Putnam, CT, a manufacturer of medical devices, revealed significant deficiencies in their quality system. The firm failed to adequately establish and implement corrective and preventive actions, properly validate manufacturing processes and equipment, and document the evaluation of contractors. These issues indicate a lack of control over critical aspects of medical device production.

## Related Officers

- [Power Trader/Data Scientist](https://www.keypedia.com/people/jeffrey-j-thibodeau/62b74030-4aef-400b-8ae2-8bf84712d813)

Company: https://www.keypedia.com/companies/carolina-precision-technologies/4b8bed20-6351-45ea-b732-2a2965ed90c1

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94