FDA Inspection
Brandt Equipment, LlcBrandt Equipment, Llc – FDA Inspection, Nov 3, 2010
Record Details
This FDA Inspection record concerns Brandt Equipment, Llc, with an inspection on November 3, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Brandt Equipment, Llc
- Inspection Date
- November 3, 2010
- Product Type
- Devices
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ID · 4caa60f0-220c-41a6-9caa-d6235a3ede63
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 697181
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.40(a)Document review, approval by designated individual
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Brandt Equipment, Llc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 13, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 31, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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