FDA Inspection
ARMOR PLAST LTDARMOR PLAST LTD – FDA Inspection, Feb 26, 2026
Record Details
This FDA Inspection record concerns ARMOR PLAST LTD, with an inspection on February 26, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · cc59ce67-0e39-4159-a62f-d279a0fdbc5f
Inspection Facts
- Inspection number
- 1304528
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
3- ISO 13485:2016 Clause 4.2.4Document Control Procedure Inadequate
- ISO 13485:2016 Clause 8.2.1Information gathered in feedback process not used as input into risk management
- ISO 13485:2016 Clause 8.4Analysis of data not used as input for QMS improvement where necessary
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Other FDA inspections of ARMOR PLAST LTD
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 19, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 4, 2015 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for ARMOR PLAST LTD
- FDA Inspection 1198686 - 2023-01-19
- FDA Inspection 954779 - 2015-12-04
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