FDA Inspection
Helena Laboratories, Corp.Helena Laboratories, Corp. – FDA Inspection, Dec 14, 2018
Record Details
This FDA Inspection record concerns Helena Laboratories, Corp., with an inspection on December 14, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · cb1d01a8-02e8-4222-96c5-3ece78757b47
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1074463
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)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 Helena Laboratories, Corp.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 21, 2017 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 1, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 29, 2010 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Helena Laboratories, Corp.
- FDA Inspection 1018711 - 2017-07-21
- FDA Inspection 820597 - 2013-03-01
- FDA Inspection 694963 - 2010-10-29
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