FDA Inspection
Bisco, Inc.Bisco, Inc. – FDA Inspection, Jun 22, 2009
Record Details
This FDA Inspection record concerns Bisco, Inc., with an inspection on June 22, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Bisco, Inc.
- Inspection Date
- June 22, 2009
- Product Type
- Devices
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ID · c5b5b6b4-645b-4350-b70c-1a8731103f28
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 591198
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 803.50(b)(1)Reporting Information Reasonably Known
- 21 CFR 820.100(a)(5)Changes to correct/prevent quality problems
- 21 CFR 820.198(d)Evaluation, timeliness, identification
- 21 CFR 820.100(a)(4)CAPA verification/validation of corrective/preventive action
- 21 CFR 820.25(b)Training
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Other FDA inspections of Bisco, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 30, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 8, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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