Company
TaiwanTAIWAN BIOTECH CO., LTD., Taoyuan City, Taiwan – FDA Inspections
Inspection records and compliance data for TAIWAN BIOTECH CO., LTD. in Taoyuan City. 6 FDA inspections on record (2 OAI), 3 Form 483s, 1 warning letter, last inspected September 20, 2022.
Company Profile
This profile covers TAIWAN BIOTECH CO., LTD. based in Taoyuan City, Taiwan.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 2
- VAI
- 2
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 3
- Warning letters
- 1
First inspected August 26, 2011. Last inspected September 20, 2022.
Most cited issue areas
- Environmental Monitoring System1 inspection
- Records reviewed annually1 inspection
- Representative Number of Batches for Annual Review1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 20, 2022 | OAI | Human Drugs · Drug Quality Assurance | 1181337 |
| September 11, 2017 | OAI | Human Drugs · Drug Quality Assurance | 1026548 |
| May 18, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1014787 |
| December 2, 2016 | Not classified | Human Drugs | 1042234 |
| May 30, 2014 | VAI | Human Drugs · Drug Quality Assurance | 885228 |
| August 26, 2011 | NAI | Human Drugs · Drug Quality Assurance | 746051 |
FDA documents
Warning Letters (1)
Other regulators (1)
People (4)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
TAIWAN BIOTECH CO., LTD.
FEI Number
3003598505
Address
Taoyuan District, 22 Chieh-Shou Rd., Taoyuan City, Taiwan
Country
Taiwan
ID: 90bf5095-2bd0-4ad1-973c-274a66a5201f