FDA Inspection
United Contact Lens, Inc.United Contact Lens, Inc. – FDA Inspection, Jun 7, 2013
Record Details
This FDA Inspection record concerns United Contact Lens, Inc., with an inspection on June 7, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- United Contact Lens, Inc.
- Inspection Date
- June 7, 2013
- Product Type
- Devices
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ID · e2db0877-f2f0-45a1-b7fe-049baa03c83f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 834873
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of United Contact Lens, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 7, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 12, 2016 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: 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 1013181 - 2017-06-07
- FDA Inspection 988717 - 2016-10-12
- FDA Inspection 729843 - 2011-06-15
- FDA Inspection 674859 - 2010-07-28
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