ALLERGAN
⚠️ Moderate Risk
FEI: 3006108784 • Heredia • COSTA RICA
FEI Number
3006108784
Location
Heredia
Country
COSTA RICAAddress
900 Parkway, Global Free Zone, La Auroa, Heredia, , Costa Rica
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 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).
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 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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/4/2014 | 78LTIIMPLANT, INTRAGASTRIC FOR MORBID OBESITY | 237NO PMA | Southwest Import District Office (SWI-DO) |
| 12/16/2011 | 79LCJEXPANDER, SKIN, INFLATABLE | New Orleans District Office (NOL-DO) | |
| 12/16/2011 | 79LCJEXPANDER, SKIN, INFLATABLE | New Orleans District Office (NOL-DO) | |
| 12/16/2011 | 79FWMPROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE | New Orleans District Office (NOL-DO) | |
| 12/16/2011 | 79FTRPROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | New Orleans District Office (NOL-DO) | |
| 5/14/2010 | 79FTRPROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | Florida District Office (FLA-DO) | |
| 11/3/2009 | 79FTRPROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | New Orleans District Office (NOL-DO) | |
| 12/17/2007 | 79FTRPROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | New Orleans District Office (NOL-DO) | |
| 12/13/2007 | 79MWZEXPANDER, BREAST, EXTERNAL | New Orleans District Office (NOL-DO) | |
| 7/10/2007 | 79FTRPROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | 237NO PMA | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is ALLERGAN's FDA import refusal history?
ALLERGAN (FEI: 3006108784) has 10 FDA import refusal record(s) in our database, spanning from 7/10/2007 to 12/4/2014.
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. ALLERGAN's FEI number is 3006108784.
What types of violations has ALLERGAN received?
ALLERGAN has been cited for 4 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 ALLERGAN come from?
All FDA import refusal data for ALLERGAN 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.