Genentech, Inc.
⚠️ High Risk
FEI: 2917293 • South San Francisco, CA • UNITED STATES
FEI Number
2917293
Location
South San Francisco, CA
Country
UNITED STATESAddress
1 DNA Way, , South San Francisco, 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).
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/3/2025 | 58MDL03TOCILIZUMAB | Division of Southeast Imports (DSEI) | |
| 12/7/2022 | 58QBK04RANIBIZUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/9/2019 | 64RCL21SOMATROPIN (HORMONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/7/2018 | 62ICE99ANTI-NEOPLASTIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/7/2016 | 65IDK03ACTIVASE | 179AGR RX | Southwest Import District Office (SWI-DO) |
| 1/6/2009 | 62IIB99ANTI-NEOPLASTIC N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/28/2008 | 60QCK40LIDOCAINE HCL (ANESTHETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/13/2007 | 63XIS99DIAGOSTIC AID (DRUGS) N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/21/2007 | 64RDY20SOMATREM (HORMONE) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/13/2007 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/14/2007 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/2/2006 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Genentech, Inc.'s FDA import refusal history?
Genentech, Inc. (FEI: 2917293) has 12 FDA import refusal record(s) in our database, spanning from 5/2/2006 to 6/3/2025.
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. Genentech, Inc.'s FEI number is 2917293.
What types of violations has Genentech, Inc. received?
Genentech, 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 Genentech, Inc. come from?
All FDA import refusal data for Genentech, 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.