Company
TaiwanPolaroisin International Co., Ltd., New Taipei City, Taiwan – FDA Inspections
Inspection records and compliance data for Polaroisin International Co., Ltd. in New Taipei City. 1 FDA inspection on record (1 OAI), 1 Form 483, 1 warning letter, last inspected September 15, 2017.
Company Profile
This profile covers Polaroisin International Co., Ltd. based in New Taipei City, Taiwan.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 1
- VAI
- 0
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 1
Inspected September 15, 2017.
Most cited issue areas
- Absence of Written Procedures1 inspection
- Complete Test Data1 inspection
- Drug products - samples representative, identified properly1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 15, 2017 | OAI | Human Drugs · Drug Quality Assurance | 1028352 |
FDA documents
Form 483s (1)
Warning Letters (1)
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Company Information
Name
Polaroisin International Co., Ltd.
FEI Number
3008004582
Address
Xinzhuang District, NO 173, 10 F; Siyuan Rd., New Taipei City, Taiwan
Country
Taiwan
ID: c9f06d5b-6111-49ca-bfa8-0e6764257851