FDA Inspection
ANDERSEN CALEDONIA LTDANDERSEN CALEDONIA LTD – FDA Inspection, May 5, 2017
Record Details
This FDA Inspection record concerns ANDERSEN CALEDONIA LTD, with an inspection on May 5, 2017, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 2aae7d4c-0bc3-4377-a0db-8a6ae4e48355
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1018335
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.70(d)Implementing Personnel Procedures, Health, Cleanliness.
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
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Other FDA inspections of ANDERSEN CALEDONIA LTD
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 18, 2025 | NAI | Office of Inspections and Investigations | Postmarket Assurance: Medical Devices |
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