FDA Inspection
Helena Laboratories, Corp.Helena Laboratories, Corp. – FDA Inspection, Jul 21, 2017
Record Details
This FDA Inspection record concerns Helena Laboratories, Corp., with an inspection on July 21, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 86bce6a3-dd81-4f06-8a99-8f01698ec8ea
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1018711
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 806.20(b)(4)Justification for not reporting
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.100(b)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 |
| 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 1074463 - 2018-12-14
- FDA Inspection 820597 - 2013-03-01
- FDA Inspection 694963 - 2010-10-29
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