FDA Inspection
CIBA VISION Johor Sdn. Bhd.CIBA VISION Johor Sdn. Bhd. – FDA Inspection, Nov 17, 2016
Record Details
This FDA Inspection record concerns CIBA VISION Johor Sdn. Bhd., with an inspection on November 17, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 013f64a2-c27d-4671-a617-b91aba3d860b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 994394
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of CIBA VISION Johor Sdn. Bhd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 24, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 28, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for CIBA VISION Johor Sdn. Bhd.
- FDA Inspection 843962 - 2013-07-24
- FDA Inspection 590119 - 2009-05-28
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