Albahealth LLC
⚠️ Moderate Risk
FEI: 1043612 • Rockwood, TN • UNITED STATES
FEI Number
1043612
Location
Rockwood, TN
Country
UNITED STATESAddress
425 N Gateway Ave, , Rockwood, TN, 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
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).
INSANITARY
The article is subject to refusal of admission pursuant to section 801(a)(3) in that the article 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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/6/2014 | 80DWLSTOCKING, MEDICAL SUPPORT | New England District Office (NWE-DO) | |
| 3/6/2014 | 80DWLSTOCKING, MEDICAL SUPPORT | New England District Office (NWE-DO) | |
| 3/6/2014 | 80DWLSTOCKING, MEDICAL SUPPORT | New England District Office (NWE-DO) |
Frequently Asked Questions
What is Albahealth LLC's FDA import refusal history?
Albahealth LLC (FEI: 1043612) has 3 FDA import refusal record(s) in our database, spanning from 3/6/2014 to 3/6/2014.
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. Albahealth LLC's FEI number is 1043612.
What types of violations has Albahealth LLC received?
Albahealth LLC 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 Albahealth LLC come from?
All FDA import refusal data for Albahealth LLC 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.