# FDA 483 - Certified Safety Mfg Inc - October 15, 2019

Source: https://www.globalkeysolutions.net/records/483/certified-safety-mfg-inc/2dea9ed2-5b09-48e3-87b5-74c80d8c394c

> FDA 483 for Certified Safety Mfg Inc on October 15, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Certified Safety Mfg Inc
- Inspection Date: 2019-10-15
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Certified Safety Mfg Inc, a manufacturer/repackager in Kansas City, MO, was cited for significant quality system deficiencies during an FDA inspection. The firm failed to adequately establish procedures for corrective and preventive actions, equipment calibration, and device history records. Several observations, including issues with nonconforming product control, quality audit frequency, and training, were repeat findings from a previous inspection.

## Related Documents

- [483 - 2025-05-15](https://www.globalkeysolutions.net/records/483/certified-safety-mfg-inc/cafc3a50-32b6-4fee-8c6e-55335ddff63a)

## Related Officers

- [Eric C. Fox](https://www.globalkeysolutions.net/people/eric-c-fox/218af117-1551-476f-80ba-172e2cd6baee)

Company: https://www.globalkeysolutions.net/companies/certified-safety-mfg-inc/e82a4fb6-6054-4ff9-a2cf-3c1d807b8e07

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8