FDA Inspection
Casco Manufacturing Solutions IncCasco Manufacturing Solutions Inc – FDA Inspection, May 10, 2012
Record Details
This FDA Inspection record concerns Casco Manufacturing Solutions Inc, with an inspection on May 10, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- May 10, 2012
- Product Type
- Devices
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ID · 6cebf5e9-cf82-484a-9cb4-9cf9bdaf1f9c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 781424
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.100(b)Documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Casco Manufacturing Solutions Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 14, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 2, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Casco Manufacturing Solutions Inc
- FDA Inspection 1109809 - 2019-11-14
- FDA Inspection 1012543 - 2017-06-02
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