SYNMR BIOTECHNOLOGY (SHANGHAI) LIMITED
⚠️ Moderate Risk
FEI: 3012029840 • Shanghai, Shanghai • CHINA
FEI Number
3012029840
Location
Shanghai, Shanghai
Country
CHINAAddress
NO. 188 Jiqiaolu, Pudongxin, 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
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.
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).
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.
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.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
HEALTH C
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/11/2018 | 54BBR01CALCIUM (MINERAL) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 8/31/2018 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 3/10/2017 | 54CBR10L-HISTADINE (PROTEIN) | Division of Southeast Imports (DSEI) | |
| 3/2/2017 | 64LAR58PREGNENOLONE SUCCINATE (GLUCOCORTICOID) | Division of Southeast Imports (DSEI) | |
| 5/11/2016 | 54FBZ99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is SYNMR BIOTECHNOLOGY (SHANGHAI) LIMITED's FDA import refusal history?
SYNMR BIOTECHNOLOGY (SHANGHAI) LIMITED (FEI: 3012029840) has 5 FDA import refusal record(s) in our database, spanning from 5/11/2016 to 12/11/2018.
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. SYNMR BIOTECHNOLOGY (SHANGHAI) LIMITED's FEI number is 3012029840.
What types of violations has SYNMR BIOTECHNOLOGY (SHANGHAI) LIMITED received?
SYNMR BIOTECHNOLOGY (SHANGHAI) LIMITED 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 SYNMR BIOTECHNOLOGY (SHANGHAI) LIMITED come from?
All FDA import refusal data for SYNMR BIOTECHNOLOGY (SHANGHAI) LIMITED 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.