FDA Inspection
Kenlor Industries, Inc.Kenlor Industries, Inc. – FDA Inspection, Sep 21, 2020
Record Details
This FDA Inspection record concerns Kenlor Industries, Inc., with an inspection on September 21, 2020, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Kenlor Industries, Inc.
- Inspection Date
- September 21, 2020
- Product Type
- Devices
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ID · e5b441b1-d244-4e7b-af4c-4e02d45cb47b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1129642
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.25(b)Training records
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.40(b)Document change records, maintained.
- 21 CFR 820.22Quality Audit/Reaudit - documentation
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Other FDA inspections of Kenlor Industries, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 3, 2019 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 2, 2017 | Not classified | Los Angeles District Office |
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