FDA Inspection
Keter Canada, Inc.Keter Canada, Inc. – FDA Inspection, Jan 31, 2019
Record Details
This FDA Inspection record concerns Keter Canada, Inc., with an inspection on January 31, 2019, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · dbb8bd12-33d9-456b-b4c5-a72eb8e101a5
Inspection Facts
- Inspection number
- 1079410
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of Keter Canada, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 5, 2025 | OAI | Office of Inspections and Investigations | Compliance: Medical Devices |
| September 23, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Keter Canada, Inc.
- FDA Inspection 1280622 - 2025-09-05
- FDA Inspection 1180322 - 2022-09-23
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