FDA Inspection
Staar Surgical CompanyStaar Surgical Company – FDA Inspection, May 18, 2018
Record Details
This FDA Inspection record concerns Staar Surgical Company, with an inspection on May 18, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · cfec41c6-6355-4d9b-b004-8227248f3a8f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1052436
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.75(a)Lack of or inadequate process validation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Staar Surgical Company
6| Date | Classification | Office | Project area |
|---|---|---|---|
| February 4, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 4, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 21, 2014 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 4, 2013 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| January 25, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Staar Surgical Company
- FDA Inspection 909104 - 2015-02-04
- FDA Inspection 909103 - 2015-02-04
- FDA Inspection 869285 - 2014-03-21
- FDA Inspection 847469 - 2013-09-04
- FDA Inspection 767761 - 2012-01-25
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