Multipack
⚠️ Moderate Risk
FEI: 3003108910 • Guerrero • MEXICO
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
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/14/2007 | 87HWCSCREW, FIXATION, BONE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 9/14/2007 | 76ELMDENTURE, PLASTIC, TEETH | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 2/14/2005 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/15/2004 | 76KIFRESIN, ROOT CANAL FILLING | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 7/12/2004 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 84RX DEVICE | New Orleans District Office (NOL-DO) |
| 9/6/2002 | 86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY | 2480RXPERSONAL | New Orleans District Office (NOL-DO) |
| 4/5/2002 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 84RX DEVICE | New Orleans District Office (NOL-DO) |
| 3/11/2002 | 86MSISOLUTION, CLEANING/LUBRICATING, ARTICIFIAL EYE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 3/11/2002 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 84RX DEVICE | New Orleans District Office (NOL-DO) |
| 1/6/2002 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 84RX DEVICE | New Orleans District Office (NOL-DO) |
| 11/18/2001 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 11/15/2001 | 66VBO99MISCELLANEOUS PATENT MEDICINES, ETC. | 472NO ENGLISH | New Orleans District Office (NOL-DO) |
| 10/16/2001 | 86HOISPECTACLE, MAGNIFYING | 84RX DEVICE | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Multipack's FDA import refusal history?
Multipack (FEI: 3003108910) has 13 FDA import refusal record(s) in our database, spanning from 10/16/2001 to 9/14/2007.
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. Multipack's FEI number is 3003108910.
What types of violations has Multipack received?
Multipack 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 Multipack come from?
All FDA import refusal data for Multipack 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.