Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd.
⚠️ Moderate Risk
FEI: 3010163919 • Wuhan, Hubei • CHINA
FEI Number
3010163919
Location
Wuhan, Hubei
Country
CHINAAddress
East Lake New Technology, No. 99 2nd Shendun Road; Development District, Wuhan, Hubei, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/28/2017 | 60LBH01ACETAMINOPHEN (ANALGESIC) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/28/2017 | 60LBH01ACETAMINOPHEN (ANALGESIC) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/28/2017 | 60LBH01ACETAMINOPHEN (ANALGESIC) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/19/2017 | 60LBH01ACETAMINOPHEN (ANALGESIC) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/19/2017 | 60LBH01ACETAMINOPHEN (ANALGESIC) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/19/2017 | 60LBH01ACETAMINOPHEN (ANALGESIC) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/19/2017 | 60LBH01ACETAMINOPHEN (ANALGESIC) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd.'s FDA import refusal history?
Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd. (FEI: 3010163919) has 7 FDA import refusal record(s) in our database, spanning from 9/19/2017 to 9/28/2017.
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. Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd.'s FEI number is 3010163919.
What types of violations has Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd. received?
Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd. has been cited for 1 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 Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd. come from?
All FDA import refusal data for Humanwell PuraCap Pharmaceuticals (Wuhan) 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.