Maycar S. A.
⚠️ Moderate Risk
FEI: 3004637760 • Capital Federal • ARGENTINA
FEI Number
3004637760
Location
Capital Federal
Country
ARGENTINAAddress
Av Chorroarin 1002, , Capital Federal, , Argentina
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).
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
NEEDS FCE
It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/23/2007 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 10/23/2007 | 85HEBTAMPON, MENSTRUAL, UNSCENTED | Los Angeles District Office (LOS-DO) | |
| 6/5/2007 | 85HHDPAD, MENSTRUAL, UNSCENTED | New York District Office (NYK-DO) | |
| 9/8/2006 | 25LGT12SWEET POTATO, DRIED OR PASTE | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Maycar S. A.'s FDA import refusal history?
Maycar S. A. (FEI: 3004637760) has 4 FDA import refusal record(s) in our database, spanning from 9/8/2006 to 10/23/2007.
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. Maycar S. A.'s FEI number is 3004637760.
What types of violations has Maycar S. A. received?
Maycar S. A. has been cited for 5 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 Maycar S. A. come from?
All FDA import refusal data for Maycar S. A. 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.