FDA Inspection
United Contact Lens, Inc.United Contact Lens, Inc. – FDA Inspection, Jun 7, 2017
Record Details
This FDA Inspection record concerns United Contact Lens, Inc., with an inspection on June 7, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Cynthia L. Gorveatt (Issuing Officer)
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ID · 9b526b40-b9dc-4a98-93b8-c936c528dda7
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1013181
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
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Other FDA inspections of United Contact Lens, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 12, 2016 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 7, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 15, 2011 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 28, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for United Contact Lens, Inc.
- FDA Inspection 988717 - 2016-10-12
- FDA Inspection 834873 - 2013-06-07
- FDA Inspection 729843 - 2011-06-15
- FDA Inspection 674859 - 2010-07-28
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