FDA Inspection
Memtec IncorporatedMemtec Incorporated – FDA Inspection, Feb 4, 2019
Record Details
This FDA Inspection record concerns Memtec Incorporated, with an inspection on February 4, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- James W. Whitney (Issuing Officer)
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ID · dea4872d-20e5-4341-b575-cfabfb0f7d3e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1079030
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.50(b)Supplier notification of changes
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Memtec Incorporated
5| Date | Classification | Office | Project area |
|---|---|---|---|
| August 6, 2021 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 20, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 6, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 31, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 26, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Memtec Incorporated
- FDA Inspection 1151504 - 2021-08-06
- FDA Inspection 949589 - 2015-11-20
- FDA Inspection 854123 - 2013-11-06
- FDA Inspection 752409 - 2011-10-31
- FDA Inspection 572524 - 2009-03-26
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