FDA Inspection
Keter Canada, Inc.Keter Canada, Inc. – FDA Inspection, Sep 5, 2025
Record Details
This FDA Inspection record concerns Keter Canada, Inc., with an inspection on September 5, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · a627c4f7-a885-40d0-9a42-fc7c0573807a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1280622
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.250(b)Sampling methods - Lack of or inadequate procedures
- 21 CFR 820.25(a)Personnel
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
Showing 10 of 12 citations.
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Other FDA inspections of Keter Canada, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 23, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 31, 2019 | Not classified | Office of Inspections and Investigations | Compliance: Devices |
Other documents for Keter Canada, Inc.
- FDA Inspection 1180322 - 2022-09-23
- FDA Inspection 1079410 - 2019-01-31
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