Company
IndiaHetero Labs Ltd. Unit VI, Mahaboob Nagar, India – FDA Inspections
Inspection records and compliance data for Hetero Labs Ltd. Unit VI in Mahaboob Nagar. 3 FDA inspections on record (1 OAI), 1 Form 483, last inspected September 21, 2023.
Company Profile
This profile covers Hetero Labs Ltd. Unit VI based in Mahaboob Nagar, India.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 1
- VAI
- 2
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected May 23, 2013. Last inspected September 21, 2023.
Most cited issue areas
- Absence of Written Procedures1 inspection
- Cleaning System1 inspection
- Control procedures to monitor and validate performance1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 21, 2023 | VAI | Human Drugs · Drug Quality Assurance | 1218220 |
| November 15, 2016 | OAI | Human Drugs · Drug Quality Assurance | 999209 |
| May 23, 2013 | VAI | Human Drugs · Drug Quality Assurance | 833134 |
FDA documents
Form 483s (1)
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Company Information
Name
Hetero Labs Ltd. Unit VI
FEI Number
3008294355
Address
Sy. No. Part Of 410, 411, Tsiic, Pharma Sez, Pollepally (V), Jadcherla (M), Mahaboob Nagar, India
Country
India
ID: e83c840a-da16-4087-9b97-86544ffddaeb