FDA Inspection
Laax, Inc.Laax, Inc. – FDA Inspection, May 22, 2015
Record Details
This FDA Inspection record concerns Laax, Inc., with an inspection on May 22, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Laax, Inc.
- Inspection Date
- May 22, 2015
- Product Type
- Devices
View Company Profile
ID · e0b7726e-6ca7-42e9-9224-7b2c885694b0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 926803
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(g)Design validation - production units
- 21 CFR 820.40(a)Document review, approval documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Laax, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 15, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Laax, Inc.
- FDA Inspection 814125 - 2013-01-15
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