Company
IndiaCONCORD BIOTECH LIMITED, Ahmedabad, India – FDA Inspections
Inspection records and compliance data for CONCORD BIOTECH LIMITED in Ahmedabad. 4 FDA inspections on record, 3 Form 483s, last inspected March 17, 2023.
Company Profile
This profile covers CONCORD BIOTECH LIMITED based in Ahmedabad, India.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 3
- NAI
- 1
- Form 483s
- 3
- Warning letters
- 0
First inspected July 21, 2017. Last inspected March 17, 2023.
Most cited issue areas
- Procedures not in writing, fully followed2 inspections
- Compositing of Sub Samples1 inspection
- Deviations from laboratory control requirements1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 17, 2023 | VAI | Human Drugs · Drug Quality Assurance | 1200525 |
| October 18, 2018 | VAI | Human Drugs · Generic Drug Evaluation | 1069171 |
| February 16, 2018 | NAI | Human Drugs · Drug Quality Assurance | 1046571 |
| July 21, 2017 | VAI | Human Drugs · New Drug Evaluation | 1021293 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
CONCORD BIOTECH LIMITED
FEI Number
3012520698
Address
297-298/2p, Siyawada, Valthera, Ahmedabad, India
Country
India
ID: 96e4c2c9-96b3-48a6-905e-575a9850db5d