Foshan Flying Medical Products Co., Ltd.
⚠️ Moderate Risk
FEI: 3009206013 • Foshan, Guangdong • CHINA
FEI Number
3009206013
Location
Foshan, Guangdong
Country
CHINAAddress
No. 49 Xiangshan 2th Road, Fengtain Industrial District, Foshan, Guangdong, 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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/18/2020 | 68ZYG99ANIMAL MEDICAL DEVICES, NEC | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 8/11/2020 | 68ZHG99ANIMAL MEDICAL DEVICES, NEC | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 1/7/2020 | 79OHOFIRST AID KIT WITHOUT DRUG | 2780DEVICEGMPS | Division of Northern Border Imports (DNBI) |
| 1/7/2020 | 79OHOFIRST AID KIT WITHOUT DRUG | 2780DEVICEGMPS | Division of Northern Border Imports (DNBI) |
| 6/27/2018 | 62HQY99ANTI-MICROBIAL N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/31/2017 | 68XYY99OTHER ANIMAL, N.E.C. DEVICE/DIAG PROD FOR ANIMAL | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 8/31/2017 | 68XYY99OTHER ANIMAL, N.E.C. DEVICE/DIAG PROD FOR ANIMAL | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 8/31/2017 | 68XYY99OTHER ANIMAL, N.E.C. DEVICE/DIAG PROD FOR ANIMAL | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 8/2/2017 | 79OHOFIRST AID KIT WITHOUT DRUG | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Foshan Flying Medical Products Co., Ltd.'s FDA import refusal history?
Foshan Flying Medical Products Co., Ltd. (FEI: 3009206013) has 9 FDA import refusal record(s) in our database, spanning from 8/2/2017 to 8/18/2020.
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. Foshan Flying Medical Products Co., Ltd.'s FEI number is 3009206013.
What types of violations has Foshan Flying Medical Products Co., Ltd. received?
Foshan Flying Medical Products Co., Ltd. has been cited for 2 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 Foshan Flying Medical Products Co., Ltd. come from?
All FDA import refusal data for Foshan Flying Medical 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.