FDA Inspection
Kenlor Industries, Inc.Kenlor Industries, Inc. – FDA Inspection, May 3, 2019
Record Details
This FDA Inspection record concerns Kenlor Industries, Inc., with an inspection on May 3, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 7ed9bca3-5a78-4308-815a-4dac99abc0e7
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1088389
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, 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 820.80(a)Lack of or inadequate procedures - Acceptance activities
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Other FDA inspections of Kenlor Industries, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 21, 2020 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 2, 2017 | Not classified | Los Angeles District Office |
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