FDA Inspection
Helena Laboratories, IncHelena Laboratories, Inc – FDA Inspection, Mar 1, 2013
Record Details
This FDA Inspection record concerns Helena Laboratories, Inc, with an inspection on March 1, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Helena Laboratories, Inc
- Inspection Date
- March 1, 2013
- Product Type
- Devices
View Company Profile
ID · a49a205c-307b-4096-9d43-4161856e8725
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 820619
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.30(f)Design verification - documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Helena Laboratories, Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 14, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 28, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Helena Laboratories, Inc
- FDA Inspection 1029048 - 2017-07-14
- FDA Inspection 695366 - 2010-10-28
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