Company
IndiaUnichem Laboratories Ltd., Ghaziabad, India – FDA Inspections
Inspection records and compliance data for Unichem Laboratories Ltd. in Ghaziabad. 7 FDA inspections on record, 2 Form 483s, last inspected February 13, 2024.
Company Profile
This profile covers Unichem Laboratories Ltd. based in Ghaziabad, India.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 4
- NAI
- 3
- Form 483s
- 2
- Warning letters
- 0
First inspected June 15, 2012. Last inspected February 13, 2024.
Most cited issue areas
- Absence of Written Procedures2 inspections
- Following/documenting laboratory controls1 inspection
- GMP Training Frequency1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 13, 2024 | NAI | Human Drugs · Drug Quality Assurance | 1230023 |
| August 23, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1102985 |
| March 8, 2019 | NAI | Human Drugs · Drug Quality Assurance | 1087477 |
| April 20, 2018 | NAI | Human Drugs · Drug Quality Assurance | 1053321 |
| March 3, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1008000 |
| March 27, 2015 | VAI | Human Drugs · Drug Quality Assurance | 922881 |
| June 15, 2012 | VAI | Human Drugs · Drug Quality Assurance | 789195 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Unichem Laboratories Ltd.
FEI Number
3004082076
Address
C - 31 & 32 Meerut Road, Ghaziabad, India
Country
India
ID: f6920640-950f-4f51-942f-92a6e5fc0e4b