The American National Red Cross Diagnostic Manufacturing Division
⚠️ Moderate Risk
FEI: 1177732 • Gaithersburg, MD • UNITED STATES
FEI Number
1177732
Location
Gaithersburg, MD
Country
UNITED STATESAddress
9319 Gaither Rd, , Gaithersburg, MD, United States
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).
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
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/3/2006 | 57DY49HUMAN SERUM ALBUMIN (BLOOD AND BLOOD DERIVATIVES) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 1/3/2006 | 57DY44SOURCE PLASMA (HUMAN) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 8/23/2004 | 57DY44SOURCE PLASMA (HUMAN) | 71NO LICENSE | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is The American National Red Cross Diagnostic Manufacturing Division's FDA import refusal history?
The American National Red Cross Diagnostic Manufacturing Division (FEI: 1177732) has 3 FDA import refusal record(s) in our database, spanning from 8/23/2004 to 1/3/2006.
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. The American National Red Cross Diagnostic Manufacturing Division's FEI number is 1177732.
What types of violations has The American National Red Cross Diagnostic Manufacturing Division received?
The American National Red Cross Diagnostic Manufacturing Division has been cited for 2 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 The American National Red Cross Diagnostic Manufacturing Division come from?
All FDA import refusal data for The American National Red Cross Diagnostic Manufacturing Division 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.