FDA Inspection
Avent, Inc.Avent, Inc. – FDA Inspection, Feb 21, 2020
Record Details
This FDA Inspection record concerns Avent, Inc., with an inspection on February 21, 2020, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Avent, Inc.
- Inspection Date
- February 21, 2020
- Product Type
- Drugs
View Company Profile
ID · 3f3dcf60-84c0-4d69-a334-9fd0019a8435
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1118646
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.192Investigations of discrepancies, failures
Full citation text and observation details available on the Dashboard.
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 |
| 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 |
| October 28, 2016 | Not classified | Denver District Office |
Other documents for Avent, Inc.
- FDA Inspection 1275741 - 2025-07-10
- FDA Inspection 1089505 - 2017-12-01
- FDA Inspection 1037129 - 2017-08-09
- FDA Inspection 994354 - 2016-11-28
- FDA Inspection 997411 - 2016-10-28
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.