FDA Inspection
Inventia Healthcare LimitedInventia Healthcare Limited – FDA Inspection, Jul 5, 2019
Record Details
This FDA Inspection record concerns Inventia Healthcare Limited, with an inspection on July 5, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · 77cf43b1-a3c3-4607-ad9d-27f9a9504512
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1096293
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.194(d)Laboratory equipment calibration records
- 21 CFR 211.192Investigations of discrepancies, failures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Inventia Healthcare Limited
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 12, 2025 | Not classified | Office of Inspections and Investigations | |
| August 21, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 10, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Inventia Healthcare Limited
- FDA Inspection 1262970 - 2025-02-12
- FDA Inspection 944555 - 2015-08-21
- FDA Inspection 833331 - 2013-05-10
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.