FDA Inspection
Avent, Inc.Avent, Inc. – FDA Inspection, Oct 28, 2011
Record Details
This FDA Inspection record concerns Avent, Inc., with an inspection on October 28, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Avent, Inc.
- Inspection Date
- October 28, 2011
- Product Type
- Devices
View Company Profile
ID · 9c7c1ab3-2810-4153-80ac-a650b9510462
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 752098
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.75(b)(2)Documentation of validated process performance
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Other FDA inspections of Avent, Inc.
11| Date | Classification | Office | Project area |
|---|---|---|---|
| July 10, 2025 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 21, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 1, 2017 | Not classified | Denver District Office | |
| August 9, 2017 | Not classified | Denver District Office | |
| November 28, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Avent, Inc.
- FDA Inspection 1275741 - 2025-07-10
- FDA Inspection 1118646 - 2020-02-21
- FDA Inspection 1089505 - 2017-12-01
- FDA Inspection 1037129 - 2017-08-09
- FDA Inspection 994354 - 2016-11-28
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