FDA Inspection
Molteno Ophthalmic LimitedMolteno Ophthalmic Limited – FDA Inspection, Dec 8, 2016
Record Details
This FDA Inspection record concerns Molteno Ophthalmic Limited, with an inspection on December 8, 2016, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- Molteno Ophthalmic Limited
- Inspection Date
- December 8, 2016
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · c1218e58-2cba-4087-93fd-23d7eea25e2d
Inspection Facts
- Inspection number
- 996558
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.40Lack of procedures, or not maintained
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Other FDA inspections of Molteno Ophthalmic Limited
5| Date | Classification | Office | Project area |
|---|---|---|---|
| December 18, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 14, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 30, 2014 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 21, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 2, 2009 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Molteno Ophthalmic Limited
- FDA Inspection 1262120 - 2024-12-18
- FDA Inspection 1113342 - 2019-11-14
- FDA Inspection 903489 - 2014-10-30
- FDA Inspection 724115 - 2011-04-21
- FDA Inspection 634822 - 2009-12-02
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