FDA Inspection
Haemonetics Software SolutionsHaemonetics Software Solutions – FDA Inspection, Mar 21, 2017
Record Details
This FDA Inspection record concerns Haemonetics Software Solutions, with an inspection on March 21, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Seema S. Singh (Issuing Officer)
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ID · dd92fa74-6300-43fa-a61a-c6f80eca5358
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1005035
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
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Other FDA inspections of Haemonetics Software Solutions
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 13, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 17, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Haemonetics Software Solutions
- FDA Inspection 866853 - 2014-02-13
- FDA Inspection 794970 - 2012-08-17
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