FDA Inspection
Spectrum Plastics GroupSpectrum Plastics Group – FDA Inspection, Oct 3, 2016
Record Details
This FDA Inspection record concerns Spectrum Plastics Group, with an inspection on October 3, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 6b1168b5-62a7-48a9-ad07-b8e7079b1a78
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 987433
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
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Other FDA inspections of Spectrum Plastics Group
4| Date | Classification | Office | Project area |
|---|---|---|---|
| December 19, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 20, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 2, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 4, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Spectrum Plastics Group
- FDA Inspection 1116166 - 2019-12-19
- FDA Inspection 891880 - 2014-08-20
- FDA Inspection 752702 - 2011-11-02
- FDA Inspection 566795 - 2009-03-04
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