Zhejiang Bohai Import And Export Co., Ltd.
⚠️ Moderate Risk
FEI: 3005885035 • Zhejiang • CHINA
FEI Number
3005885035
Location
Zhejiang
Country
CHINAAddress
302 Room, No. 546, Chouzhou Road, , Zhejiang, , China
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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/23/2007 | 89IPRCRUTCH | Atlanta District Office (ATL-DO) | |
| 8/23/2007 | 76EFWTOOTHBRUSH, MANUAL | Atlanta District Office (ATL-DO) | |
| 8/23/2007 | 53IY01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 8/23/2007 | 53JY99OTHER PERSONAL CLEANLINESS PRODUCTS (NOT ANTIPERSPIRANT), N.E.C. | 75UNAPPROVED | Atlanta District Office (ATL-DO) |
Frequently Asked Questions
What is Zhejiang Bohai Import And Export Co., Ltd.'s FDA import refusal history?
Zhejiang Bohai Import And Export Co., Ltd. (FEI: 3005885035) has 4 FDA import refusal record(s) in our database, spanning from 8/23/2007 to 8/23/2007.
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. Zhejiang Bohai Import And Export Co., Ltd.'s FEI number is 3005885035.
What types of violations has Zhejiang Bohai Import And Export Co., Ltd. received?
Zhejiang Bohai Import And Export 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 Zhejiang Bohai Import And Export Co., Ltd. come from?
All FDA import refusal data for Zhejiang Bohai Import And Export 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.