Company
IndiaHetero Labs Ltd. - Unit IX, Visakhapatnam, India – FDA Inspections
Inspection records and compliance data for Hetero Labs Ltd. - Unit IX in Visakhapatnam. 6 FDA inspections on record (1 OAI), 3 Form 483s, last inspected September 26, 2025.
Company Profile
This profile covers Hetero Labs Ltd. - Unit IX based in Visakhapatnam, India.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 1
- VAI
- 3
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 3
- Warning letters
- 0
First inspected December 15, 2011. Last inspected September 26, 2025.
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 26, 2025 | Not classified | Human Drugs | 1297806 |
| November 8, 2022 | VAI | Human Drugs · Drug Quality Assurance | 1193038 |
| May 14, 2019 | OAI | Human Drugs · Drug Quality Assurance | 1089874 |
| August 18, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1024034 |
| September 29, 2014 | VAI | Human Drugs · Drug Quality Assurance | 898993 |
| December 15, 2011 | NAI | Human Drugs · Drug Quality Assurance | 779428 |
FDA documents
People (6)
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Company Information
Name
Hetero Labs Ltd. - Unit IX
FEI Number
3009093782
Address
Unit Ix, Plot No. 2, Hetero Infrastructure Sez, Narasapuram Village, Nakkapalli Mandal, Visakhapatnam, India
Country
India
ID: b44e59b6-5413-4ef1-83a3-411f3684bdc3