Ningbo Powerwell Fine Chemical Industrial Co., Ltd.
⚠️ Moderate Risk
FEI: 3004823229 • Ningbo • CHINA
FEI Number
3004823229
Location
Ningbo
Country
CHINAAddress
Gao Qiao Industrial Development Zone,, Yinzhou District, Ningbo, , 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
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).
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).
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/4/2010 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Detroit District Office (DET-DO) | |
| 8/15/2007 | 76NXZKIT, DENTAL HYGIENE | 75UNAPPROVED | Baltimore District Office (BLT-DO) |
| 8/15/2007 | 63RBL04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | Baltimore District Office (BLT-DO) |
| 6/8/2006 | 53LC02DEPILATORIES (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Ningbo Powerwell Fine Chemical Industrial Co., Ltd.'s FDA import refusal history?
Ningbo Powerwell Fine Chemical Industrial Co., Ltd. (FEI: 3004823229) has 4 FDA import refusal record(s) in our database, spanning from 6/8/2006 to 10/4/2010.
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. Ningbo Powerwell Fine Chemical Industrial Co., Ltd.'s FEI number is 3004823229.
What types of violations has Ningbo Powerwell Fine Chemical Industrial Co., Ltd. received?
Ningbo Powerwell Fine Chemical Industrial 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 Ningbo Powerwell Fine Chemical Industrial Co., Ltd. come from?
All FDA import refusal data for Ningbo Powerwell Fine Chemical Industrial 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.