FDA Inspection
Moor Instruments LtdMoor Instruments Ltd – FDA Inspection, May 6, 2011
Record Details
This FDA Inspection record concerns Moor Instruments Ltd, with an inspection on May 6, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Moor Instruments Ltd
- Inspection Date
- May 6, 2011
- Product Type
- Devices
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ID · 90ccc663-9946-402b-9d4f-9faa71f10e79
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 730020
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.198(a)Complaints
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.40(a)Document review, approval documentation
- 21 CFR 820.20(c)Management review dates
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Moor Instruments Ltd
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 27, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 7, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 5, 2017 | VAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| August 21, 2014 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Moor Instruments Ltd
- FDA Inspection 1191843 - 2022-10-27
- FDA Inspection 1109984 - 2019-11-07
- FDA Inspection 1031124 - 2017-05-05
- FDA Inspection 894791 - 2014-08-21
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