FDA Inspection
Gebauer CompanyGebauer Company – FDA Inspection, Jan 26, 2012
Record Details
This FDA Inspection record concerns Gebauer Company, with an inspection on January 26, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Gebauer Company
- Inspection Date
- January 26, 2012
- Product Type
- Devices
View Company Profile
ID · ee208af5-0d96-4d0b-9b60-ada706ce917f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 764672
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 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 Gebauer Company
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 15, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 26, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Gebauer Company
- FDA Inspection 954359 - 2015-12-15
- FDA Inspection 825525 - 2013-03-26
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