FDA Inspection
The LifeStyle Company, Inc.The LifeStyle Company, Inc. – FDA Inspection, Mar 6, 2017
Record Details
This FDA Inspection record concerns The LifeStyle Company, Inc., with an inspection on March 6, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Melissa A. Zuppe
View Company Profile
ID · 33a39d70-b7f2-48da-ab18-553ca3fd9728
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1009023
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.40(a)Document review, approval by designated individual
- 21 CFR 820.25(a)Personnel
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of The LifeStyle Company, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 27, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 29, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 5, 2008 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for The LifeStyle Company, Inc.
- FDA Inspection 884993 - 2014-06-27
- FDA Inspection 747004 - 2011-09-29
- FDA Inspection 545471 - 2008-11-05
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