FDA Inspection
UABUAB – FDA Inspection, Jan 21, 2025
Record Details
This FDA Inspection record concerns UAB, with an inspection on January 21, 2025, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 3afdeabb-b371-4266-bb89-3e373f03aeaa
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1258773
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
12- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.250(b)Sampling plans
Showing 10 of 12 citations.
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Other FDA inspections of UAB
4| Date | Classification | Office | Project area |
|---|---|---|---|
| December 19, 2024 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| December 13, 2024 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| December 3, 2024 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| August 23, 2019 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
Other documents for UAB
- FDA Inspection 1260949 - 2024-12-19
- FDA Inspection 1260766 - 2024-12-13
- FDA Inspection 1258581 - 2024-12-03
- FDA Inspection 1100973 - 2019-08-23
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