FDA Inspection
GVS Filter Technology UK, Ltd.GVS Filter Technology UK, Ltd. – FDA Inspection, Sep 8, 2016
Record Details
This FDA Inspection record concerns GVS Filter Technology UK, Ltd., with an inspection on September 8, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 8, 2016
- Product Type
- Devices
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ID · d6cadc86-8e54-43b1-abf7-9ea8179e2c06
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 988254
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
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Other FDA inspections of GVS Filter Technology UK, Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 1, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 24, 2014 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for GVS Filter Technology UK, Ltd.
- FDA Inspection 1231709 - 2024-02-01
- FDA Inspection 893034 - 2014-07-24
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