Research Pharmaceutical Ltd
⚠️ High Risk
FEI: 3009309093 • Shanghai • CHINA
FEI Number
3009309093
Location
Shanghai
Country
CHINAAddress
Rm C Fl 21st No 971 Dongfang Rd, , 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
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).
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).
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 |
|---|---|---|---|
| 6/20/2016 | 62OAB22CARVEDILOL (ANTI-HYPERTENSIVE - PART II) | Florida District Office (FLA-DO) | |
| 6/20/2016 | 60SAA13MAGNESIUM CARBONATE (ANTACID) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/20/2016 | 62FAA34POVIDONE IODINE (ANTI-INFECTIVE, TOPICAL) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/20/2016 | 61HCA03TRIMETHOPRIM (ANTI-BACTERIAL) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/20/2016 | 61ECA09MONTELUKAST SODIUM (ANTI-ASTHMATIC) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/20/2016 | 64HDA01BROMHEXINE HCL (EXPECTORANT) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/20/2016 | 56BAA05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/20/2016 | 55RG70BORIC ACID (PHARMACEUTIC NECESSITY) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/20/2016 | 60LCA01ACETAMINOPHEN (ANALGESIC) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/14/2016 | 62KAE08LOPERAMIDE HYDROCHLORIDE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | Division of Southeast Imports (DSEI) | |
| 6/14/2016 | 62OAB24DILTIAZEM HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | Division of Southeast Imports (DSEI) | |
| 6/14/2016 | 61WCB45FLUCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | Division of Southeast Imports (DSEI) | |
| 6/14/2016 | 65PAA02SILDENAFIL CITRATE (REGULATOR) | Division of Southeast Imports (DSEI) | |
| 6/14/2016 | 61ECA06FEXOFENADINE HCL (ANTI-ASTHMATIC) | Division of Southeast Imports (DSEI) | |
| 6/14/2016 | 61TAB31DOMPERIDONE | Division of Southeast Imports (DSEI) | |
| 3/29/2016 | 60LCA01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/17/2016 | 66BAA05CAFFEINE (STIMULANT) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/17/2016 | 62ODS20CAPTOPRIL (ANTI-HYPERTENSIVE - PART II) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/7/2015 | 62FAA34POVIDONE IODINE (ANTI-INFECTIVE, TOPICAL) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 10/7/2015 | 54CDR23L-CARNITINE (PROTEIN) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/5/2015 | 64BCS24FUROSEMIDE (DIURETIC) | Florida District Office (FLA-DO) | |
| 10/5/2015 | 60SCA23METOCLOPRAMIDE (ANTACID) | Florida District Office (FLA-DO) | |
| 10/5/2015 | 65QAL37AMINOPHYLLINE (RELAXANT) | Florida District Office (FLA-DO) | |
| 6/11/2015 | 60IBB01POTASSIUM CITRATE (ALKALIZER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/11/2015 | 60IAB12SODIUM CITRATE (ALKALIZER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/22/2015 | 64HDA99EXPECTORANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/7/2015 | 55PP56ISOPROPYL MYRISTATE (PHARMACEUTIC NECESSITY - EMOLLIENT) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 5/7/2015 | 62VCA18ACYCLOVIR (ANTI-VIRAL) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 5/7/2015 | 62ODZ12VALSARTAN (ANTI-HYPERTENSIVE - PART II) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 5/7/2015 | 61HCA03TRIMETHOPRIM (ANTI-BACTERIAL) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 5/7/2015 | 56BAA05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 5/7/2015 | 62OCB05RAMIPRIL (ANTI-HYPERTENSIVE - PART II) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 5/7/2015 | 56BAK55OXACILLIN SODIUM (PENICILLIN, SYNTHETICALLY PRODUCED) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 5/7/2015 | 62CAR41MINOXIDIL (ANTI-HYPERTENSIVE) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 5/7/2015 | 62ODZ37IRBESARTAN (ANTI-HYPERTENSIVE - PART II) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 5/7/2015 | 62OCA28ENALAPRIL MALEATE (ANTI-HYPERTENSIVE - PART II) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 5/7/2015 | 61FAB56CLARITHROMYCIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 5/7/2015 | 62ODS20CAPTOPRIL (ANTI-HYPERTENSIVE - PART II) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 5/7/2015 | 56ICB76AZITHROMYCIN (MACAROLIDES) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 5/7/2015 | 55PP31BENZYL ALCOHOL (PHARMACEUTIC NECESSITY - ANTIMICROBIAL AGENT) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 5/7/2015 | 60WCA01ALBENDAZOLE (ANTHELMINTIC) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 5/7/2015 | 55RP52STEARIC ACID (PHARMACEUTIC NECESSITY - TABLET LUBRICANT) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 5/7/2015 | 60LCA01ACETAMINOPHEN (ANALGESIC) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 5/7/2015 | 55PP68PROPYLENE GLYCOL MONOSTEARATE (PHARMACEUTIC NECESSITY - EMULSIFYING AGENT) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 5/7/2015 | 62GAA46KETOPROFEN (ANTI-INFLAMMATORY) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 3/17/2015 | 64HDA01BROMHEXINE HCL (EXPECTORANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/17/2015 | 61LCA38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/17/2015 | 60LAA14CARBAMAZEPINE (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/17/2015 | 63BAA35CLENBUTEROL (BRONCHODILATOR) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 1/12/2015 | 50BGY30COLOR FOR DRUG (NOT CERTIFIED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/6/2015 | 60LCA01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/23/2014 | 62FAA34POVIDONE IODINE (ANTI-INFECTIVE, TOPICAL) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/23/2014 | 60LCA01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/16/2014 | 62OAA41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | Florida District Office (FLA-DO) | |
| 10/16/2014 | 66BAA05CAFFEINE (STIMULANT) | Florida District Office (FLA-DO) | |
| 8/21/2014 | 56OAA02MOXIFLOXACIN HCL (FLUOROQUINOLONE) | Division of Southeast Imports (DSEI) | |
| 8/5/2014 | 62GDL90DICLOFENAC POTASSIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/5/2014 | 54ADA12FOLIC ACID (VITAMIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/5/2014 | 62ODZ12VALSARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/28/2014 | 64HDA01BROMHEXINE HCL (EXPECTORANT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 4/11/2014 | 56BBB03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | Florida District Office (FLA-DO) | |
| 4/11/2014 | 56BAA05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | Florida District Office (FLA-DO) | |
| 3/24/2014 | 60LAL21DIPYRONE (ANALGESIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/12/2014 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/12/2014 | 60WCA01ALBENDAZOLE (ANTHELMINTIC) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/12/2014 | 61NAA69GABAPENTIN (ANTI-DEPRESSANT) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/12/2014 | 62GDL18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/12/2014 | 62UBA11DEXTROMETHORPHAN HYDROBROMIDE (ANTI-TUSSIVE/COLD) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2014 | 62OCB05RAMIPRIL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 2/19/2014 | 60LCL99ANALGESIC, N.E.C. | Florida District Office (FLA-DO) | |
| 2/11/2014 | 60IBB01POTASSIUM CITRATE (ALKALIZER) | Division of Southeast Imports (DSEI) | |
| 2/5/2014 | 62ODZ37IRBESARTAN (ANTI-HYPERTENSIVE - PART II) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/24/2014 | 60IAB12SODIUM CITRATE (ALKALIZER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/8/2014 | 61HCA03TRIMETHOPRIM (ANTI-BACTERIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/17/2013 | 60LCA01ACETAMINOPHEN (ANALGESIC) | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Research Pharmaceutical Ltd's FDA import refusal history?
Research Pharmaceutical Ltd (FEI: 3009309093) has 75 FDA import refusal record(s) in our database, spanning from 12/17/2013 to 6/20/2016.
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. Research Pharmaceutical Ltd's FEI number is 3009309093.
What types of violations has Research Pharmaceutical Ltd received?
Research Pharmaceutical Ltd has been cited for 3 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 Research Pharmaceutical Ltd come from?
All FDA import refusal data for Research Pharmaceutical 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.