FDA Inspection
GVS Filter Technology UK, Ltd.GVS Filter Technology UK, Ltd. – FDA Inspection, Jul 24, 2014
Record Details
This FDA Inspection record concerns GVS Filter Technology UK, Ltd., with an inspection on July 24, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- July 24, 2014
- Product Type
- Devices
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ID · b2a975f4-6272-4d18-a313-da1011fc9ba3
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 893034
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
12- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(c)Documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
Showing 10 of 12 citations.
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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 |
| September 8, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for GVS Filter Technology UK, Ltd.
- FDA Inspection 1231709 - 2024-02-01
- FDA Inspection 988254 - 2016-09-08
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