Shanghai Huazhou PSA Products Co., Ltd.
⚠️ Moderate Risk
FEI: 3003844446 • Shanghai, Shanghai • CHINA
FEI Number
3003844446
Location
Shanghai, Shanghai
Country
CHINAAddress
FLOOR 1-3, BULIDING 22,NO1_ 28, LANE 588, TIANXIONG ROAD, ZHOUPU TOWN, PUDONG NEW DISTRICT, Shanghai, Shanghai, 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
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/26/2013 | 80FRLFIBER, MEDICAL, ABSORBENT | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 5/5/2008 | 89MLXPAD, MEDICATED, ADHESIVE, NON-ELECTRIC | Baltimore District Office (BLT-DO) | |
| 5/5/2008 | 89MLXPAD, MEDICATED, ADHESIVE, NON-ELECTRIC | Baltimore District Office (BLT-DO) | |
| 5/2/2008 | 80KGXTAPE AND BANDAGE, ADHESIVE | Baltimore District Office (BLT-DO) | |
| 5/1/2008 | 80KGXTAPE AND BANDAGE, ADHESIVE | Baltimore District Office (BLT-DO) | |
| 4/15/2008 | 89MLXPAD, MEDICATED, ADHESIVE, NON-ELECTRIC | Baltimore District Office (BLT-DO) | |
| 3/20/2008 | 89MLXPAD, MEDICATED, ADHESIVE, NON-ELECTRIC | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Shanghai Huazhou PSA Products Co., Ltd.'s FDA import refusal history?
Shanghai Huazhou PSA Products Co., Ltd. (FEI: 3003844446) has 7 FDA import refusal record(s) in our database, spanning from 3/20/2008 to 9/26/2013.
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. Shanghai Huazhou PSA Products Co., Ltd.'s FEI number is 3003844446.
What types of violations has Shanghai Huazhou PSA Products Co., Ltd. received?
Shanghai Huazhou PSA Products Co., Ltd. has been cited for 4 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 Shanghai Huazhou PSA Products Co., Ltd. come from?
All FDA import refusal data for Shanghai Huazhou PSA Products 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.