FDA Inspection
Snyder Industries BensenvilleSnyder Industries Bensenville – FDA Inspection, Aug 8, 2014
Record Details
This FDA Inspection record concerns Snyder Industries Bensenville, with an inspection on August 8, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 8, 2014
- Product Type
- Devices
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ID · eedebf19-fd82-4c11-906a-b5733889fa8c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 897713
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
18- 21 CFR 820.80(e)Documentation
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.40(a)Document review, approval by designated individual
- 21 CFR 820.72(a)Equipment control activity documentation
- 21 CFR 820.120(d)Records, DHR {see also 820.184(e)}
- 21 CFR 820.25(b)Training records
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
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Other FDA inspections of Snyder Industries Bensenville
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 14, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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