National Institute For Biological Standards And Control
⚠️ Moderate Risk
FEI: 1000181118 • Potters Bar, Hertfordshire • UNITED KINGDOM
FEI Number
1000181118
Location
Potters Bar, Hertfordshire
Country
UNITED KINGDOMAddress
P.O. Box 1193, Blanche Lane, Potters Bar, Hertfordshire, United Kingdom
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
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
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).
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/23/2015 | 75JHIRADIOIMMUNOASSAY, HUMAN CHORIONIC GONADOTROPIN | Division of Northern Border Imports (DNBI) | |
| 9/30/2015 | 75CEWRADIOIMMUNOASSAY, PARATHYROID HORMONE | 341REGISTERED | Division of Northern Border Imports (DNBI) |
| 9/30/2015 | 82DHXSYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN | 341REGISTERED | Division of Northern Border Imports (DNBI) |
| 9/30/2015 | 82JNLIMMUNOCHEMICAL, THYROGLOBULIN AUTOANTIBODY | 341REGISTERED | Division of Northern Border Imports (DNBI) |
| 9/30/2015 | 82JZOSYSTEM, TEST, THYROID AUTOANTIBODY | 341REGISTERED | Division of Northern Border Imports (DNBI) |
| 9/18/2015 | 57BL01DIPHTHERIA TOXOID | 71NO LICENSE | New York District Office (NYK-DO) |
| 9/18/2015 | 57UL06TETANUS IMMUNE GLOBULIN | 71NO LICENSE | New York District Office (NYK-DO) |
| 9/18/2015 | 57BL05TETANUS TOXOID | 71NO LICENSE | New York District Office (NYK-DO) |
| 9/18/2015 | 57BL05TETANUS TOXOID | 71NO LICENSE | New York District Office (NYK-DO) |
| 9/18/2015 | 57BL01DIPHTHERIA TOXOID | 71NO LICENSE | New York District Office (NYK-DO) |
| 9/18/2015 | 57BL05TETANUS TOXOID | 71NO LICENSE | New York District Office (NYK-DO) |
| 10/31/2005 | 82NAFANTIGEN (COMPLEXED), PROSTATE SPECIFIC (CPSA) | Cincinnati District Office (CIN-DO) | |
| 3/14/2005 | 57CJ02INFLUENZA VIRUS VACCINE | 27DRUG GMPS | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is National Institute For Biological Standards And Control's FDA import refusal history?
National Institute For Biological Standards And Control (FEI: 1000181118) has 13 FDA import refusal record(s) in our database, spanning from 3/14/2005 to 11/23/2015.
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. National Institute For Biological Standards And Control's FEI number is 1000181118.
What types of violations has National Institute For Biological Standards And Control received?
National Institute For Biological Standards And Control has been cited for 6 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 National Institute For Biological Standards And Control come from?
All FDA import refusal data for National Institute For Biological Standards And Control 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.