FDA Inspection
Cellay, IncCellay, Inc – FDA Inspection, Feb 10, 2016
Record Details
This FDA Inspection record concerns Cellay, Inc, with an inspection on February 10, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Cellay, Inc
- Inspection Date
- February 10, 2016
- Product Type
- Devices
View Company Profile
ID · e16c2582-ca3d-4510-a917-30cfc78f5142
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 960939
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 806.10(a)(2)Report of violation of the Act (see 803.52(e)(9))
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.70(i)Documentation of software validation
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Other FDA inspections of Cellay, Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 18, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Cellay, Inc
- FDA Inspection 667333 - 2010-06-18
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