FDA Inspection
Intas Pharmaceuticals LimitedIntas Pharmaceuticals Limited – FDA Inspection, Jun 8, 2018
Record Details
This FDA Inspection record concerns Intas Pharmaceuticals Limited, with an inspection on June 8, 2018, issued by the Center for Veterinary Medicine, covering veterinary.
- People
- Abby E. Pelletier (Issuing Officer)
- Matthew B. Casale (FDA Associated Person)
View Company Profile
ID · 40778dca-3416-4505-9b4f-98131521219b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1056170
- FDA center
- Animal Drugs & Feeds
- Project area
- Pre-Approval Eval. of Animal Drugs and Food Additives
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.192Investigations of discrepancies, failures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Intas Pharmaceuticals Limited
14| Date | Classification | Office | Project area |
|---|---|---|---|
| July 12, 2024 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| May 12, 2023 | Not classified | Office of Inspections and Investigations | |
| August 2, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 14, 2018 | VAI | Center for Drug Evaluation and Research | Generic Drug Evaluation |
| August 17, 2018 | Not classified | Office of Inspections and Investigations |
Other documents for Intas Pharmaceuticals Limited
- FDA Inspection 1245599 - 2024-07-12
- FDA Inspection 1206170 - 2023-05-12
- FDA Inspection 1098380 - 2019-08-02
- FDA Inspection 1074349 - 2018-12-14
- FDA Inspection 1067525 - 2018-08-17
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.