FDA Inspection
Control Devices - Carr LaneControl Devices - Carr Lane – FDA Inspection, Mar 28, 2017
Record Details
This FDA Inspection record concerns Control Devices - Carr Lane, with an inspection on March 28, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 79f852e9-3893-413a-8b70-6b18cd01f6df
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1009753
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Control Devices - Carr Lane
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 15, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 14, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Control Devices - Carr Lane
- FDA Inspection 832345 - 2013-05-15
- FDA Inspection 611151 - 2009-09-14
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