Shire Biologics, Div. of Shire Biochem Inc.
⚠️ Moderate Risk
FEI: 3003561471 • Sainte-Foy, QC • CANADA
FEI Number
3003561471
Location
Sainte-Foy, QC
Country
CANADAAddress
2323 Parc Technologies Blvd, , Sainte-Foy, QC, Canada
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
NO LICENSE
The article is subject to refusal of admission under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it appears to be a biological product for which a biologics license is not in effect under the Public Health Service Act, Part F, Subpart 1-Biological Products, Section 351(a), and it is not the subject of an Investigational New Drug application that is in effect. Therefore, it appears to be a new drug under 201(p) of the FD&C Act that it is in violation of section 505(a) of the FD&C Act because it lacks a new drug approval and because it is misbranded under section 502(f)(1)of the FD&C Act because it fails to bear adequate directions for use
STERILITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/28/2005 | 57CC02INFLUENZA VIRUS VACCINE | New Orleans District Office (NOL-DO) | |
| 2/1/2005 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 71NO LICENSE | New Orleans District Office (NOL-DO) |
| 1/31/2005 | 57CY02INFLUENZA VIRUS VACCINE | New Orleans District Office (NOL-DO) | |
| 12/16/2004 | 57CY02INFLUENZA VIRUS VACCINE | 71NO LICENSE | New Orleans District Office (NOL-DO) |
| 12/6/2004 | 57CY02INFLUENZA VIRUS VACCINE | 27DRUG GMPS | Cincinnati District Office (CIN-DO) |
| 11/21/2003 | 57CC02INFLUENZA VIRUS VACCINE | 71NO LICENSE | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Shire Biologics, Div. of Shire Biochem Inc.'s FDA import refusal history?
Shire Biologics, Div. of Shire Biochem Inc. (FEI: 3003561471) has 6 FDA import refusal record(s) in our database, spanning from 11/21/2003 to 9/28/2005.
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. Shire Biologics, Div. of Shire Biochem Inc.'s FEI number is 3003561471.
What types of violations has Shire Biologics, Div. of Shire Biochem Inc. received?
Shire Biologics, Div. of Shire Biochem Inc. 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 Shire Biologics, Div. of Shire Biochem Inc. come from?
All FDA import refusal data for Shire Biologics, Div. of Shire Biochem 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.