# FDA 483 - Hi-Dow International Inc - September 15, 2022

Source: https://www.globalkeysolutions.net/records/483/hi-dow-international-inc/2ec2bef2-510c-4163-9010-c3dc959655ab

> FDA 483 for Hi-Dow International Inc on September 15, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hi-Dow International Inc
- Inspection Date: 2022-09-15
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Hi-Dow International Inc., a specification developer and complaint file establishment for Class II Transcutaneous Nerve Stimulators (TENS) in Maryland Heights, MO, received a Form FDA-483 with seven observations. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate complaint handling, lack of design controls, and insufficient corrective and preventive actions. Many of these issues were repeat observations from previous inspections, indicating a persistent failure to establish and maintain a compliant quality system.

## Related Documents

- [483 - 2019-12-05](https://www.globalkeysolutions.net/records/483/hi-dow-international-inc/85c2e8a0-4150-4cc4-96d5-6268818bde4e)

## Related Officers

- [Eric C. Fox](https://www.globalkeysolutions.net/people/eric-c-fox/218af117-1551-476f-80ba-172e2cd6baee)
- [Edward E. Lockwood](https://www.globalkeysolutions.net/people/edward-e-lockwood/3260b39e-9211-489f-8247-0ec3353e57ca)

Company: https://www.globalkeysolutions.net/companies/hi-dow-international-inc/7aaaa08a-dcd7-4643-9578-cf2f0ff6195c

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