FDA Inspection
Instratek, IncorporatedInstratek, Incorporated – FDA Inspection, Mar 24, 2014
Record Details
This FDA Inspection record concerns Instratek, Incorporated, with an inspection on March 24, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Instratek, Incorporated
- Inspection Date
- March 24, 2014
- Product Type
- Devices
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ID · 7a51e8b0-a0f8-4f57-988a-d9254f03cca4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 868891
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.30(e)Design review - documentation
- 21 CFR 820.50(a)(1)Documented evaluation
- 21 CFR 820.30(g)Design validation - documentation
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Other FDA inspections of Instratek, Incorporated
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 24, 2012 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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