SHANGHAI TRIFECTA PHARMA, CO.LTD.
⚠️ High Risk
FEI: 3008367099 • Shanghai, Shanghai • CHINA
FEI Number
3008367099
Location
Shanghai, Shanghai
Country
CHINAAddress
Yueda Inter. Tower South Pudong Rd. Ste.1313 1088, 1118 Chang Shou Road; Pudong, Shanghai, Shanghai, China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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.
NEEDS FCE
It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/19/2015 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/19/2015 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/19/2015 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/19/2015 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/19/2015 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/19/2015 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/19/2015 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/7/2015 | 56CCK70CEFTRIAXONE SODIUM (CEPHALOSPORINS) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/7/2015 | 56CCK60CEFOTAXIME SODIUM (CEPHALOSPORINS) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/7/2015 | 56BAA05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/7/2015 | 60LAL21DIPYRONE (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/7/2015 | 62GDL18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/1/2015 | 56IIY10ERYTHROMYCIN (MACROLIDES) | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 9/12/2012 | 56BAA05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | Division of Southeast Imports (DSEI) | |
| 8/13/2012 | 54ADB13VITAMIN C (ASCORBIC ACID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/13/2012 | 60SCA23METOCLOPRAMIDE (ANTACID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/13/2012 | 56DCK21GENTAMICIN SULFATE (AMINOGLYCOSIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/13/2012 | 62GDL18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/13/2012 | 64LAA20DEXAMETHASONE SODIUM PHOSPHATE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/13/2012 | 61KAB05ATROPINE SULFATE (ANTI-CHOLINERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/13/2012 | 65QAL37AMINOPHYLLINE (RELAXANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/13/2012 | 56YYK99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/13/2012 | 54ADB05VITAMIN B12 (CYANOCOBALAMIN) | 62NEEDS FCE | Division of Southeast Imports (DSEI) |
| 5/30/2012 | 62GDL18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 5/30/2012 | 56BAA05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | Division of Southeast Imports (DSEI) | |
| 3/19/2012 | 64LCA41HYDROCORTISONE SODIUM SUCCINATE (GLUCOCORTICOID) | Division of Southeast Imports (DSEI) | |
| 12/4/2011 | 56CCA11CEFAZOLIN SODIUM (CEPHALOSPORINS) | Florida District Office (FLA-DO) | |
| 12/4/2011 | 64LCA41HYDROCORTISONE SODIUM SUCCINATE (GLUCOCORTICOID) | Florida District Office (FLA-DO) | |
| 11/28/2011 | 62KAE10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | Division of Southeast Imports (DSEI) | |
| 11/28/2011 | 56CCK60CEFOTAXIME SODIUM (CEPHALOSPORINS) | Division of Southeast Imports (DSEI) | |
| 11/28/2011 | 56CCA58CEFOPERAZONE SODIUM (CEPHALOSPORINS) | Division of Southeast Imports (DSEI) | |
| 11/28/2011 | 56CCK70CEFTRIAXONE SODIUM (CEPHALOSPORINS) | Division of Southeast Imports (DSEI) | |
| 11/28/2011 | 56BAA05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | Division of Southeast Imports (DSEI) | |
| 11/28/2011 | 56BAA05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | Division of Southeast Imports (DSEI) | |
| 11/28/2011 | 56BAA05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | Division of Southeast Imports (DSEI) | |
| 11/23/2011 | 56BAA05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | Division of Southeast Imports (DSEI) | |
| 11/23/2011 | 56BAA05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | Division of Southeast Imports (DSEI) | |
| 11/23/2011 | 56BAA05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | Division of Southeast Imports (DSEI) | |
| 11/23/2011 | 64LAA20DEXAMETHASONE SODIUM PHOSPHATE (GLUCOCORTICOID) | Division of Southeast Imports (DSEI) | |
| 11/23/2011 | 64LAA20DEXAMETHASONE SODIUM PHOSPHATE (GLUCOCORTICOID) | Division of Southeast Imports (DSEI) | |
| 11/23/2011 | 56BAA05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | Division of Southeast Imports (DSEI) | |
| 11/23/2011 | 56BAA05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | Division of Southeast Imports (DSEI) | |
| 11/23/2011 | 56BAA05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | Division of Southeast Imports (DSEI) | |
| 11/23/2011 | 64LAA20DEXAMETHASONE SODIUM PHOSPHATE (GLUCOCORTICOID) | Division of Southeast Imports (DSEI) | |
| 11/23/2011 | 64LAA20DEXAMETHASONE SODIUM PHOSPHATE (GLUCOCORTICOID) | Division of Southeast Imports (DSEI) | |
| 11/23/2011 | 56BAA05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | Division of Southeast Imports (DSEI) | |
| 11/23/2011 | 56BAA05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | Division of Southeast Imports (DSEI) | |
| 11/23/2011 | 56BAA05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | Division of Southeast Imports (DSEI) | |
| 11/23/2011 | 62GDL18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 10/20/2010 | 62KAE10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/18/2010 | 56CCK60CEFOTAXIME SODIUM (CEPHALOSPORINS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/31/2010 | 56BAK55OXACILLIN SODIUM (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 8/31/2010 | 56BAA05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 7/1/2010 | 62GDL18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/1/2010 | 54ADL18VITAMIN K (PHYTONADIONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/1/2010 | 64BCS24FUROSEMIDE (DIURETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/1/2010 | 62GDL18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/1/2010 | 56CCA58CEFOPERAZONE SODIUM (CEPHALOSPORINS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/1/2010 | 56CCA25SODIUM CEPHALOTHIN (CEPHALOSPORINS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is SHANGHAI TRIFECTA PHARMA, CO.LTD.'s FDA import refusal history?
SHANGHAI TRIFECTA PHARMA, CO.LTD. (FEI: 3008367099) has 59 FDA import refusal record(s) in our database, spanning from 7/1/2010 to 10/19/2015.
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. SHANGHAI TRIFECTA PHARMA, CO.LTD.'s FEI number is 3008367099.
What types of violations has SHANGHAI TRIFECTA PHARMA, CO.LTD. received?
SHANGHAI TRIFECTA PHARMA, 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 SHANGHAI TRIFECTA PHARMA, CO.LTD. come from?
All FDA import refusal data for SHANGHAI TRIFECTA PHARMA, 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.