Company
MalaysiaBiocon Sdn. Bhd. (Company No. 201101002193), Johor, Malaysia – FDA Inspections
Inspection records and compliance data for Biocon Sdn. Bhd. (Company No. 201101002193) in Johor. 4 FDA inspections on record, 4 Form 483s, last inspected September 27, 2024.
Company Profile
This profile covers Biocon Sdn. Bhd. (Company No. 201101002193) based in Johor, Malaysia.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 0
- NAI
- 0
- Unclassified
- 4
- Form 483s
- 4
- Warning letters
- 0
First inspected February 15, 2018. Last inspected September 27, 2024.
Most cited issue areas
- Environmental Monitoring System1 inspection
- Investigations of discrepancies, failures1 inspection
- Lab controls established, including changes1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 27, 2024 | Not classified | Human Drugs | 1251607 |
| July 20, 2023 | Not classified | Medical Devices & Rad Health | 1215012 |
| July 5, 2019 | Not classified | Human Drugs, Medical Devices & Rad Health · Compliance: Devices | 1095222 |
| February 15, 2018 | Not classified | Human Drugs | 1044083 |
FDA documents
People (6)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Biocon Sdn. Bhd. (Company No. 201101002193)
FEI Number
3011248248
Address
No. 1., Jalan Biooteknologi 1, Kawasan Perindustrian Silc, Johor, 79200 Iskandar Puteri, Malaysia
Country
Malaysia
ID: b7eb03f4-676c-44c0-af88-528fbc4236a8