Company
IndiaUnichem Laboratories Limited, Pilerne Bardez, India – FDA Inspections
Inspection records and compliance data for Unichem Laboratories Limited in Pilerne Bardez. 8 FDA inspections on record, 3 Form 483s, last inspected September 26, 2026.
Company Profile
This profile covers Unichem Laboratories Limited based in Pilerne Bardez, India.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 0
- VAI
- 6
- NAI
- 0
- Unclassified
- 2
- Form 483s
- 3
- Warning letters
- 0
First inspected May 15, 2009. Last inspected September 26, 2026.
Most cited issue areas
- Computer control of master formula records1 inspection
- Investigations of discrepancies, failures1 inspection
- Lack of quality control unit1 inspection
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 26, 2026 | Not classified | Human Drugs | 1337024 |
| July 15, 2024 | VAI | Human Drugs · Drug Quality Assurance | 1243288 |
| January 12, 2020 | VAI | Human Drugs · Drug Quality Assurance | 1159456 |
| July 31, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1102049 |
| March 20, 2017 | Not classified | Human Drugs | 1009098 |
| April 17, 2015 | VAI | Human Drugs · Drug Quality Assurance | 922923 |
| April 6, 2012 | VAI | Human Drugs · Drug Quality Assurance | 777002 |
| May 15, 2009 | VAI | Human Drugs · Drug Quality Assurance | 591445 |
FDA documents
Form 483s (2)
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Company Information
Name
Unichem Laboratories Limited
FEI Number
3005497507
Address
Plot No. 10 To 18, Pilerne Industrial Estate, Pilerne Bardez, India
Country
India
ID: 2b8c7905-52a2-4b2e-a97e-0a1d5b2d88ea