FDA Inspection
Voss Plastics, Inc.Voss Plastics, Inc. – FDA Inspection, Sep 12, 2014
Record Details
This FDA Inspection record concerns Voss Plastics, Inc., with an inspection on September 12, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Voss Plastics, Inc.
- Inspection Date
- September 12, 2014
- Product Type
- Devices
View Company Profile
ID · e4a2fdf7-2520-441a-91b8-01937f73734a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 896784
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
9- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 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 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Voss Plastics, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 4, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Voss Plastics, Inc.
- FDA Inspection 963332 - 2016-03-04
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