Chugai Pharma Manufacturing Co. Ltd.
⚠️ Moderate Risk
FEI: 3006942691 • Utsunomiya, Tochigi • JAPAN
FEI Number
3006942691
Location
Utsunomiya, Tochigi
Country
JAPANAddress
16-3 Utsunomiya Plant, Kiyoharakogyodanchi, Utsunomiya, Tochigi, Japan
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/12/2018 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/9/2018 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 3/9/2018 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 3/9/2018 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Chugai Pharma Manufacturing Co. Ltd.'s FDA import refusal history?
Chugai Pharma Manufacturing Co. Ltd. (FEI: 3006942691) has 4 FDA import refusal record(s) in our database, spanning from 3/9/2018 to 3/12/2018.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Chugai Pharma Manufacturing Co. Ltd.'s FEI number is 3006942691.
What types of violations has Chugai Pharma Manufacturing Co. Ltd. received?
Chugai Pharma Manufacturing Co. Ltd. has been cited for 3 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Chugai Pharma Manufacturing Co. Ltd. come from?
All FDA import refusal data for Chugai Pharma Manufacturing Co. Ltd. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.