MCA Medical And Chemical Agency S.R.L.
⚠️ Moderate Risk
FEI: 1000167943 • San Vittore Olona, MI • ITALY
FEI Number
1000167943
Location
San Vittore Olona, MI
Country
ITALYAddress
Via Parini, 13, , San Vittore Olona, MI, Italy
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
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
RX LEGEND
The article appears to be a prescription drug without a prescription drug legend as required by Section 503(b)(4).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/8/2021 | 64LAJ67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 9/11/2017 | 64LDJ28FLUOCINONIDE (GLUCOCORTICOID) | Division of Northeast Imports (DNEI) | |
| 9/7/2017 | 64LCJ28FLUOCINONIDE (GLUCOCORTICOID) | Division of Northeast Imports (DNEI) | |
| 1/6/2015 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Baltimore District Office (BLT-DO) | |
| 9/4/2014 | 64LDJ28FLUOCINONIDE (GLUCOCORTICOID) | Division of Northeast Imports (DNEI) | |
| 9/4/2014 | 64LDJ67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | Division of Northeast Imports (DNEI) | |
| 5/4/2011 | 64LDO67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 5/4/2011 | 64LDO28FLUOCINONIDE (GLUCOCORTICOID) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/6/2009 | 64LCJ28FLUOCINONIDE (GLUCOCORTICOID) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 4/6/2009 | 64LDJ06BETAMETHASONE DIPROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 8/5/2008 | 64LDJ28FLUOCINONIDE (GLUCOCORTICOID) | Los Angeles District Office (LOS-DO) | |
| 8/5/2008 | 64LDJ28FLUOCINONIDE (GLUCOCORTICOID) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 8/7/2007 | 64LDJ28FLUOCINONIDE (GLUCOCORTICOID) | New York District Office (NYK-DO) | |
| 8/7/2007 | 64LDJ67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | New York District Office (NYK-DO) | |
| 5/5/2006 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 5/1/2006 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 3/22/2006 | 63VCJ02HYDROQUINONE (DEPIGMENTOR) | New Orleans District Office (NOL-DO) | |
| 4/14/2004 | 64LDJ67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | New York District Office (NYK-DO) | |
| 12/30/2003 | 64LDO28FLUOCINONIDE (GLUCOCORTICOID) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 1/4/2002 | 66BIY99STIMULANT N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is MCA Medical And Chemical Agency S.R.L.'s FDA import refusal history?
MCA Medical And Chemical Agency S.R.L. (FEI: 1000167943) has 20 FDA import refusal record(s) in our database, spanning from 1/4/2002 to 6/8/2021.
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. MCA Medical And Chemical Agency S.R.L.'s FEI number is 1000167943.
What types of violations has MCA Medical And Chemical Agency S.R.L. received?
MCA Medical And Chemical Agency S.R.L. has been cited for 9 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 MCA Medical And Chemical Agency S.R.L. come from?
All FDA import refusal data for MCA Medical And Chemical Agency S.R.L. 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.