FDA Inspection
Galentic Pharma (India) Pvt. LtdGalentic Pharma (India) Pvt. Ltd – FDA Inspection, Aug 11, 2026
Record Details
This FDA Inspection record concerns Galentic Pharma (India) Pvt. Ltd, with an inspection on August 11, 2026, issued by the Office of Inspections and Investigations, covering human drugs.
View Company Profile
ID · 34a19983-bf8a-441b-b91f-e43d8cb1428a
Inspection Facts
- Inspection number
- 1330534
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.165(a)Testing and release for distribution
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Galentic Pharma (India) Pvt. Ltd
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 8, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 21, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 24, 2017 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Galentic Pharma (India) Pvt. Ltd
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.