Guilin Sanjin Pharmaceutical Co Ltd
⚠️ Moderate Risk
FEI: 3008995345 • Guilin, Guangxizhuangzuzizhiqu • CHINA
FEI Number
3008995345
Location
Guilin, Guangxizhuangzuzizhiqu
Country
CHINAAddress
No. 9 Ren Min Road, Linguixian, Guilin, Guangxizhuangzuzizhiqu, 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.
UNSFDIETSP
The article appears to be a dietary supplement or ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/9/2023 | 54YCL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Division of West Coast Imports (DWCI) | |
| 9/29/2015 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 7/31/2013 | 33CGT06FLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITH FRUIT (WITHOUT CHOCOLATE) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 7/31/2013 | 33CGT06FLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITH FRUIT (WITHOUT CHOCOLATE) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 7/31/2013 | 66V99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 12/20/2012 | 54FEA99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 2120UNSFDIETSP | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Guilin Sanjin Pharmaceutical Co Ltd's FDA import refusal history?
Guilin Sanjin Pharmaceutical Co Ltd (FEI: 3008995345) has 6 FDA import refusal record(s) in our database, spanning from 12/20/2012 to 5/9/2023.
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. Guilin Sanjin Pharmaceutical Co Ltd's FEI number is 3008995345.
What types of violations has Guilin Sanjin Pharmaceutical Co Ltd received?
Guilin Sanjin Pharmaceutical Co Ltd has been cited for 6 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 Guilin Sanjin Pharmaceutical Co Ltd come from?
All FDA import refusal data for Guilin Sanjin 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.