FDA Inspection
Halyard North Carolina, LLCHalyard North Carolina, LLC – FDA Inspection, Jun 3, 2013
Record Details
This FDA Inspection record concerns Halyard North Carolina, LLC, with an inspection on June 3, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Halyard North Carolina, LLC
- Inspection Date
- June 3, 2013
- Product Type
- Devices
View Company Profile
ID · 626f0c08-b133-4deb-a182-6c996b8d439b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 834402
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
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Other FDA inspections of Halyard North Carolina, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 11, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 14, 2016 | Not classified | Atlanta District Office | |
| August 18, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Halyard North Carolina, LLC
- FDA Inspection 1205560 - 2023-04-11
- FDA Inspection 1005073 - 2016-10-14
- FDA Inspection 676285 - 2010-08-18
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