Company
IndiaAmneal Pharmaceuticals Pvt. Ltd., Tal Bavla, Ahmedabad, India – FDA Inspections
Inspection records and compliance data for Amneal Pharmaceuticals Pvt. Ltd. in Tal Bavla, Ahmedabad. 8 FDA inspections on record, 1 Form 483, last inspected July 14, 2023.
Company Profile
This profile covers Amneal Pharmaceuticals Pvt. Ltd. based in Tal Bavla, Ahmedabad, India.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 0
- VAI
- 3
- NAI
- 5
- Form 483s
- 1
- Warning letters
- 0
First inspected August 17, 2012. Last inspected July 14, 2023.
Most cited issue areas
- Failure to meet specifications1 inspection
- Habits of good sanitation & health1 inspection
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 14, 2023 | NAI | Human Drugs · Drug Quality Assurance | 1216256 |
| February 21, 2020 | NAI | Human Drugs · Drug Quality Assurance | 1121776 |
| May 24, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1091111 |
| August 24, 2018 | NAI | Human Drugs · Drug Quality Assurance | 1067930 |
| September 22, 2017 | NAI | Human Drugs · Drug Quality Assurance | 1031432 |
| April 12, 2017 | NAI | Human Drugs · Drug Quality Assurance | 1011379 |
| January 30, 2015 | VAI | Human Drugs · Drug Quality Assurance | 915281 |
| August 17, 2012 | VAI | Human Drugs · Drug Quality Assurance | 795243 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Amneal Pharmaceuticals Pvt. Ltd.
FEI Number
3008223599
Address
Survey 634, 637 to 641 Near Hotel Kankavati, Sarkhej Bavla Highway, Rajoda, Tal Bavla, Ahmedabad, India
Country
India
ID: d9511eee-eb35-4200-ab7c-20384b82bfa6