FDA Inspection
United Contact Lens, Inc.United Contact Lens, Inc. – FDA Inspection, Oct 12, 2016
Record Details
This FDA Inspection record concerns United Contact Lens, Inc., with an inspection on October 12, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d831be82-23fe-4840-a854-0b5610f95150
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 988717
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR 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 |
| 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 1013181 - 2017-06-07
- FDA Inspection 834873 - 2013-06-07
- FDA Inspection 729843 - 2011-06-15
- FDA Inspection 674859 - 2010-07-28
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