FDA Inspection
Specialty TintSpecialty Tint – FDA Inspection, Oct 15, 2008
Record Details
This FDA Inspection record concerns Specialty Tint, with an inspection on October 15, 2008, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Specialty Tint
- Inspection Date
- October 15, 2008
- Product Type
- Devices
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ID · 292faefc-8415-4a1f-a496-932067b55d84
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 541753
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.80(e)Documentation
- 21 CFR 820.70(c)Environmental control system periodic inspections
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.70(i)Documentation of software validation
- 21 CFR 820.40(a)Document review, approval documentation
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Other FDA inspections of Specialty Tint
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 6, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Specialty Tint
- FDA Inspection 981331 - 2016-07-06
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