FDA Inspection
DR. BROWN'S COMPANYDR. BROWN'S COMPANY – FDA Inspection, Apr 23, 2026
Record Details
This FDA Inspection record concerns DR. BROWN'S COMPANY, with an inspection on April 23, 2026, issued by the Kansas City District Office, covering medical devices & rad health.
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ID · 838c30b3-e220-4014-b3c4-6ceeb682317a
Inspection Facts
- Inspection number
- 1313602
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.35(a)Lack of justification for not investigating complaints requiring investigation
- ISO 13485:2016 Clause 7.4.2Purchasing information does not include all required elements
- ISO 13485:2016 Clause 7.5.6Process for production and service provision not validated
- ISO 13485:2016 Clause 8.2.6Monitoring and measurement requirements of product characteristics are not met
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Other FDA inspections of DR. BROWN'S COMPANY
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 31, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 23, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for DR. BROWN'S COMPANY
- FDA Inspection 853355 - 2013-10-31
- FDA Inspection 710432 - 2011-02-23
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