Gilead Sciences, Inc.
⚠️ High Risk
FEI: 1000523075 • Foster City, CA • UNITED STATES
FEI Number
1000523075
Location
Foster City, CA
Country
UNITED STATESAddress
333 Lakeside Dr, , Foster City, CA, United States
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).
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/12/2024 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/28/2023 | 62VDA50EMTRICITABINE | Division of Southeast Imports (DSEI) | |
| 9/22/2022 | 66VCB99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/31/2020 | 62VDA76EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMERATE (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/25/2016 | 62VDC12RIBAVIRIN (ANTI-VIRAL) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 4/28/2015 | 62FAA99ANTI-INFECTIVE, TOPICAL N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 4/4/2013 | 62VIY50EMTRICITABINE | Florida District Office (FLA-DO) | |
| 4/3/2013 | 62VDA24EFAVIRENZ (ANTI-VIRAL) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 8/23/2011 | 62VCB15TENOFOVIR DISOPROXIL FUMERATE | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/14/2009 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 7/14/2009 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
Frequently Asked Questions
What is Gilead Sciences, Inc.'s FDA import refusal history?
Gilead Sciences, Inc. (FEI: 1000523075) has 11 FDA import refusal record(s) in our database, spanning from 7/14/2009 to 11/12/2024.
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. Gilead Sciences, Inc.'s FEI number is 1000523075.
What types of violations has Gilead Sciences, Inc. received?
Gilead Sciences, Inc. 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 Gilead Sciences, Inc. come from?
All FDA import refusal data for Gilead Sciences, Inc. 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.