Kaiping Genuine Biochemical Pharmaceutical Co,. Ltd.
⚠️ Moderate Risk
FEI: 3011330475 • Kaiping, Guangdong • CHINA
FEI Number
3011330475
Location
Kaiping, Guangdong
Country
CHINAAddress
No.1, Xinke Road, Biaohai Industrial Zone, Shatang Town, Kaiping, 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
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/18/2023 | 54YBY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 8/4/2015 | 54YBR99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 7/13/2015 | 54YBR99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 8/8/2014 | 63ECZ18ADENOSINE (CARDIAC DEPRESSANT (ANTI-ARRHYTHMIC)) | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Kaiping Genuine Biochemical Pharmaceutical Co,. Ltd.'s FDA import refusal history?
Kaiping Genuine Biochemical Pharmaceutical Co,. Ltd. (FEI: 3011330475) has 4 FDA import refusal record(s) in our database, spanning from 8/8/2014 to 8/18/2023.
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. Kaiping Genuine Biochemical Pharmaceutical Co,. Ltd.'s FEI number is 3011330475.
What types of violations has Kaiping Genuine Biochemical Pharmaceutical Co,. Ltd. received?
Kaiping Genuine Biochemical Pharmaceutical 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 Kaiping Genuine Biochemical Pharmaceutical Co,. Ltd. come from?
All FDA import refusal data for Kaiping Genuine Biochemical Pharmaceutical 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.