# FDA 483 - C&A TOOL - March 02, 2022

Source: https://www.globalkeysolutions.net/records/483/ca-tool/75ba4fe0-8652-469d-8081-a445f62d6bdb

> FDA 483 for C&A TOOL on March 02, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: C&A TOOL
- Inspection Date: 2022-03-02
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: C&A Tool, a medical device manufacturer in Auburn, IN, was cited for five significant quality system deficiencies during an FDA inspection. The observations primarily concern inadequate procedures for process control, process validation, corrective and preventive actions, control of nonconforming product, and complaint handling. These issues indicate a systemic lack of established and followed quality management practices.

## Related Officers

- [Brian M Marosan](https://www.globalkeysolutions.net/people/brian-m-marosan/7954e296-d16b-4a87-b773-038732777bb8)
- [ Investigator ](https://www.globalkeysolutions.net/people/suyang-qin/c32419c5-1b78-4014-9f94-cb7ab17dfe05)

Company: https://www.globalkeysolutions.net/companies/ca-tool/70e9e6fc-3eff-4c65-b741-46cf338c197f

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0