FDA Inspection
Aerogen Ltd.Aerogen Ltd. – FDA Inspection, Mar 31, 2011
Record Details
This FDA Inspection record concerns Aerogen Ltd., with an inspection on March 31, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Aerogen Ltd.
- Inspection Date
- March 31, 2011
- Product Type
- Devices
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ID · df22f61f-b0e1-4910-94ad-aca7480344be
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 718124
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
1- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Aerogen Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 11, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Aerogen Ltd.
- FDA Inspection 1062144 - 2018-05-11
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