FDA Inspection
The Lifestyle GP Company, LLCThe Lifestyle GP Company, LLC – FDA Inspection, Jan 29, 2013
Record Details
This FDA Inspection record concerns The Lifestyle GP Company, LLC, with an inspection on January 29, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- January 29, 2013
- Product Type
- Devices
View Company Profile
ID · c5ec9087-c046-401b-a66e-69e40790d078
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 816123
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.80(b)Incoming acceptance records, documentation
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of The Lifestyle GP Company, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 19, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 31, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 5, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for The Lifestyle GP Company, LLC
- FDA Inspection 1001734 - 2017-01-19
- FDA Inspection 853828 - 2013-10-31
- FDA Inspection 586308 - 2009-06-05
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