# FDA 483 - Aunt Flow Corp - October 07, 2021

Source: https://www.keypedia.com/records/483/aunt-flow-corp/d5231e9b-3aaf-4718-9e0b-5b0d3fd5fc5d

> FDA 483 for Aunt Flow Corp on October 07, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aunt Flow Corp
- Inspection Date: 2021-10-07
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: Aunt Flow Corp, a medical device importer and distributor in Columbus, OH, was inspected by the FDA and received eight observations. The inspection revealed significant deficiencies across its quality system, citing a complete lack of established procedures for critical areas such as complaint handling, training, quality audits, design control, purchasing controls, quality policy, management review, and document control. These findings indicate a fundamental absence of a compliant quality management system.

## Related Documents

- [483 - 2025-05-08](https://www.keypedia.com/records/483/aunt-flow-corp/6d33844c-4901-4462-8f34-641bcc68ce44)

## Related Officers

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

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

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