# FDA 483 - Aunt Flow Corp - May 08, 2025

Source: https://www.globalkeysolutions.net/records/483/aunt-flow-corp/6d33844c-4901-4462-8f34-641bcc68ce44

> FDA 483 for Aunt Flow Corp on May 08, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aunt Flow Corp
- Inspection Date: 2025-05-08
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: Aunt Flow Corp, a medical device specification developer in Columbus, OH, received a Form FDA 483 with seven observations, many of which are repeat issues from a previous inspection. The observations highlight significant deficiencies across multiple critical quality system areas, including supplier management, CAPA, complaint handling, design control, training, management review, and quality audits. This indicates a systemic failure to establish and implement adequate procedures for quality assurance.

## Related Documents

- [483 - 2021-10-07](https://www.globalkeysolutions.net/records/483/aunt-flow-corp/d5231e9b-3aaf-4718-9e0b-5b0d3fd5fc5d)

## Related Officers

- [Medical Device Specialist](https://www.globalkeysolutions.net/people/rosanna-m-goodrich/44c5c743-f67b-41fe-9cd1-8b5913bf580e)

Company: https://www.globalkeysolutions.net/companies/aunt-flow-corp/92f3eacb-eb47-4c91-a59d-672e275dc131

Office: https://www.globalkeysolutions.net/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22