Jiangsu Nanfang Medical Co., Ltd.
⚠️ Moderate Risk
FEI: 3003514271 • Changzhou, Jiangsu • CHINA
FEI Number
3003514271
Location
Changzhou, Jiangsu
Country
CHINAAddress
Wujin, 1 Guoxiang Road; Economic Development Zone, Changzhou, Jiangsu, 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
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.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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).
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
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).
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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
POISONOUS
The article is subject to refusal of admission pursuant Section 801(a)(3) in that The cosmetic appears to bear or contain a poisonous or deleterious substance which may render it injurious to users under the conditions prescribed in the labeling thereof, or, under such conditions of use as are customary or usual.
DANGEROUS
The article appears to be dangerous to health when used in the dosage or manner, or with the frequency or duration, prescribed, recommended, or suggested in the labeling thereof.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/18/2016 | 80KGXTAPE AND BANDAGE, ADHESIVE | 223FALSE | Division of Northern Border Imports (DNBI) |
| 1/14/2016 | 79KGXTAPE AND BANDAGE, ADHESIVE | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 6/10/2015 | 80KGXTAPE AND BANDAGE, ADHESIVE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 6/10/2015 | 80KGXTAPE AND BANDAGE, ADHESIVE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 5/28/2015 | 80KGXTAPE AND BANDAGE, ADHESIVE | Los Angeles District Office (LOS-DO) | |
| 5/28/2015 | 80KGXTAPE AND BANDAGE, ADHESIVE | Los Angeles District Office (LOS-DO) | |
| 4/24/2015 | 80KGXTAPE AND BANDAGE, ADHESIVE | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 2/3/2014 | 80KGXTAPE AND BANDAGE, ADHESIVE | Los Angeles District Office (LOS-DO) | |
| 1/15/2014 | 80KGXTAPE AND BANDAGE, ADHESIVE | Los Angeles District Office (LOS-DO) | |
| 6/17/2008 | 53LF04FOOT POWDERS AND SPRAYS (SKIN CARE PREPARATIONS) | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Jiangsu Nanfang Medical Co., Ltd.'s FDA import refusal history?
Jiangsu Nanfang Medical Co., Ltd. (FEI: 3003514271) has 10 FDA import refusal record(s) in our database, spanning from 6/17/2008 to 11/18/2016.
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. Jiangsu Nanfang Medical Co., Ltd.'s FEI number is 3003514271.
What types of violations has Jiangsu Nanfang Medical Co., Ltd. received?
Jiangsu Nanfang Medical Co., Ltd. has been cited for 9 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 Jiangsu Nanfang Medical Co., Ltd. come from?
All FDA import refusal data for Jiangsu Nanfang Medical 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.