Holland America Line -
⚠️ Moderate Risk
FEI: 1000132620 • Seattle, WA • UNITED STATES
FEI Number
1000132620
Location
Seattle, WA
Country
UNITED STATESAddress
300 Elliott Ave W, , Seattle, WA, 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
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.
EXPIRED
the product strength differs from, or its purity or quality falls below, that which it purports or is represented to possess in that it is past its labeled expiration date.
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).
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).
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.
AGRINSULIN
The article appears to be composed wholly or partly of insulin manufactured in the US and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for a medical emergency
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 |
|---|---|---|---|
| 3/31/2014 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 179AGR RX | Seattle District Office (SEA-DO) |
| 3/31/2014 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 179AGR RX | Seattle District Office (SEA-DO) |
| 3/24/2014 | 81LOQDEVICE, GENERAL PURPOSE HEMATOLOGY | Florida District Office (FLA-DO) | |
| 6/5/2013 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 179AGR RX | Seattle District Office (SEA-DO) |
| 5/22/2013 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 179AGR RX | Seattle District Office (SEA-DO) |
| 2/22/2013 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 179AGR RX | Seattle District Office (SEA-DO) |
| 2/22/2013 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 179AGR RX | Seattle District Office (SEA-DO) |
| 9/26/2012 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | Seattle District Office (SEA-DO) | |
| 8/10/2012 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | Seattle District Office (SEA-DO) | |
| 7/25/2012 | 62VCK31INTERFERON ALFA-2B, RECOMBINANT/RIBAVIRI (ANTI-VIRAL) | Cincinnati District Office (CIN-DO) | |
| 1/18/2012 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 6/23/2008 | 61LCK22ANTI-COAGULANT HEPARIN SOL | 179AGR RX | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Holland America Line -'s FDA import refusal history?
Holland America Line - (FEI: 1000132620) has 12 FDA import refusal record(s) in our database, spanning from 6/23/2008 to 3/31/2014.
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. Holland America Line -'s FEI number is 1000132620.
What types of violations has Holland America Line - received?
Holland America Line - has been cited for 8 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 Holland America Line - come from?
All FDA import refusal data for Holland America Line - 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.