FDA Inspection
One Lambda IncOne Lambda Inc – FDA Inspection, May 18, 2016
Record Details
This FDA Inspection record concerns One Lambda Inc, with an inspection on May 18, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- One Lambda Inc
- Inspection Date
- May 18, 2016
- Product Type
- Devices
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ID · fbc486d4-dabb-471d-8332-a3c7ac1116c3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 975304
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.86Acceptance status
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Other FDA inspections of One Lambda Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 10, 2017 | Not classified | Los Angeles District Office | |
| September 10, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 13, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for One Lambda Inc
- FDA Inspection 1028992 - 2017-02-10
- FDA Inspection 896974 - 2014-09-10
- FDA Inspection 734327 - 2011-07-13
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