FDA Inspection
Novartis Pharma Produktions GmbHNovartis Pharma Produktions GmbH – FDA Inspection, Sep 15, 2011
Record Details
This FDA Inspection record concerns Novartis Pharma Produktions GmbH, with an inspection on September 15, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 15, 2011
- Product Type
- Drugs
View Company Profile
ID · df80c33d-6bd5-4e77-a1d2-87315c0ef7e7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 748066
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.180(e)(1)Review of representative number of batches
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Novartis Pharma Produktions GmbH
6| Date | Classification | Office | Project area |
|---|---|---|---|
| July 11, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 3, 2023 | Not classified | Office of Inspections and Investigations | |
| September 27, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 19, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 18, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Novartis Pharma Produktions GmbH
- FDA Inspection 1268304 - 2024-07-11
- FDA Inspection 1217481 - 2023-08-03
- FDA Inspection 1108037 - 2019-09-27
- FDA Inspection 1015619 - 2017-05-19
- FDA Inspection 934282 - 2015-06-18
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.