# DR. BROWN'S COMPANY – FDA 483, Apr 23, 2026

Source: https://www.keypedia.com/records/483/dr-browns-company/49476b05-31dd-40f7-99c6-3bb9dc825b88

> FDA 483 for DR. BROWN'S COMPANY on April 23, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: DR. BROWN'S COMPANY
- Inspection Date: 2026-04-23
- Product Type: device
- Office Name: Kansas City District Office
- Summary: An FDA inspection of Dr. Brown's Company, a specification developer and U.S. distributor of AquaCool Water-Filled Teethers, revealed significant deficiencies in their quality system. The firm failed to adequately monitor product characteristics, validate sterilization and biocompatibility processes, establish proper purchasing controls with suppliers, and investigate product complaints. These issues indicate a lack of robust quality assurance for a Class II medical device.

## Related Officers

- [Edward E. Lockwood](https://www.keypedia.com/people/edward-e-lockwood/3260b39e-9211-489f-8247-0ec3353e57ca)

Company: https://www.keypedia.com/companies/dr-browns-company/a62586b7-4c51-46dd-98d4-ba6f42f98b9c

Office: https://www.keypedia.com/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79