# FDA 483 - Caution Wear Corporation - January 10, 2020

Source: https://www.globalkeysolutions.net/records/483/caution-wear-corporation/73724ecd-4632-4bb4-b961-0450ef4f3618

> FDA 483 for Caution Wear Corporation on January 10, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Caution Wear Corporation
- Inspection Date: 2020-01-10
- Product Type: device
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: Caution Wear Corporation in Nashua, NH, a labeler/relabeler, was cited for significant deficiencies in its quality system during an FDA inspection. The firm lacked established procedures for handling complaints, implementing corrective and preventive actions, and ensuring the quality of purchased products and services. These issues indicate a fundamental absence of critical quality management processes.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/jonathan-b-lewis/dc2d7eb9-275b-44fc-960d-9cf22d54768f)

Company: https://www.globalkeysolutions.net/companies/caution-wear-corporation/81f8a50a-ead1-4bd1-aa80-88dd8bd257a9

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7