FDA Inspection
Helena Laboratories, Corp.Helena Laboratories, Corp. – FDA Inspection, Mar 1, 2013
Record Details
This FDA Inspection record concerns Helena Laboratories, Corp., with an inspection on March 1, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Helena Laboratories, Corp.
- Inspection Date
- March 1, 2013
- Product Type
- Devices
View Company Profile
ID · 92e8404f-4bfd-4aba-8b2d-bf38577293de
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 820597
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.30(g)Design validation - documentation
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Other FDA inspections of Helena Laboratories, Corp.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 14, 2018 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 21, 2017 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 29, 2010 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Helena Laboratories, Corp.
- FDA Inspection 1074463 - 2018-12-14
- FDA Inspection 1018711 - 2017-07-21
- FDA Inspection 694963 - 2010-10-29
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