Gulf Pharmaceutical Industries - Julphar
⚠️ Moderate Risk
FEI: 3004504829 • Ras Al Khaimah, Ras Al Khaimah • UNITED ARAB EMIRATES
FEI Number
3004504829
Location
Ras Al Khaimah, Ras Al Khaimah
Country
UNITED ARAB EMIRATESAddress
Airport Rd, , Ras Al Khaimah, Ras Al Khaimah, United Arab Emirates
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).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/30/2021 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 7/31/2019 | 66VAA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/4/2017 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 3/20/2017 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 3/17/2017 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 3/17/2017 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 5/3/2016 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 27DRUG GMPS | New Orleans District Office (NOL-DO) |
| 5/3/2016 | 62FBJ99ANTI-INFECTIVE, TOPICAL N.E.C. | 27DRUG GMPS | New Orleans District Office (NOL-DO) |
| 4/26/2016 | 56YAJ99ANTIBIOTIC N.E.C. | 27DRUG GMPS | New Orleans District Office (NOL-DO) |
| 3/19/2015 | 61PDY11GLYBURIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 1/13/2015 | 60LAC05ASPIRIN (ANALGESIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/19/2012 | 65LPJ99PROTECTANT N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/11/2007 | 64BCA25HYDROCHLOROTHIAZIDE (DIURETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/11/2007 | 62OCB22CARVEDILOL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/12/2005 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Gulf Pharmaceutical Industries - Julphar's FDA import refusal history?
Gulf Pharmaceutical Industries - Julphar (FEI: 3004504829) has 15 FDA import refusal record(s) in our database, spanning from 12/12/2005 to 11/30/2021.
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. Gulf Pharmaceutical Industries - Julphar's FEI number is 3004504829.
What types of violations has Gulf Pharmaceutical Industries - Julphar received?
Gulf Pharmaceutical Industries - Julphar 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 Gulf Pharmaceutical Industries - Julphar come from?
All FDA import refusal data for Gulf Pharmaceutical Industries - Julphar 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.