FDA Inspection
CIBA Vision Puerto Rico, Inc.CIBA Vision Puerto Rico, Inc. – FDA Inspection, Sep 2, 2010
Record Details
This FDA Inspection record concerns CIBA Vision Puerto Rico, Inc., with an inspection on September 2, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 2, 2010
- Product Type
- Devices
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ID · 30bd2d61-ff5f-4838-914a-666359956c40
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 682591
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.120(b)Examination for accuracy
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
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Other FDA inspections of CIBA Vision Puerto Rico, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 21, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 9, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for CIBA Vision Puerto Rico, Inc.
- FDA Inspection 739834 - 2011-07-21
- FDA Inspection 637948 - 2009-12-09
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