ImportRefusal LogoImportRefusal

MONACO

MONACO

FDA import refusal data for products from MONACO

21
Total Firms
418
Total Refusals
4/24/2024
Latest Refusal

Common Violations

226

NOT LISTED

162

UNAPPROVED

11

NO PROCESS

7

CSTIC LBLG

6

NEEDS FCE

4

COSM COLOR

3

LABELING

3

DIRECTIONS

2

LACKS N/C

2

FRNMFGREG

Top Firms

#Firm NameRiskRefusals
1Risk: 71.4212
2Risk: 60.9118
3Risk: 48.444
4Risk: 51.311
5Risk: 35.58
6
Fernando Pensato

Monte Carlo

Risk: 55.04
7
Sofamo

Monaco

Risk: 45.73
8Risk: 33.03
9Risk: 28.43
10Risk: 24.31
11Risk: 16.31
12Risk: 39.51
13Risk: 20.31
14Risk: 32.31
15Risk: 40.31
16Risk: 40.31
17Risk: 20.31
18
SED

Monaco

Risk: 32.31
19Risk: 40.31
20Risk: 24.31

Frequently Asked Questions

How many FDA import refusals are from MONACO?

According to FDA records, there have been 418 import refusals for products originating from MONACO, involving 21 firms.

What products from MONACO are commonly refused by the FDA?

Products from MONACO may be refused for various reasons including adulteration, misbranding, lack of proper registration, or failure to meet U.S. safety standards. The specific products vary by firm and time period. View the common violations section on this page for more details.

Does an import refusal mean products from MONACO are unsafe?

Not necessarily. An import refusal indicates a specific shipment appeared to violate FDA requirements at the time of inspection. Many MONACO firms successfully import products that meet all FDA requirements. Import refusals help identify and prevent non-compliant products from entering the U.S. market.

How current is the FDA import refusal data for MONACO?

Our database includes FDA import refusals for MONACO through 4/24/2024. Data is sourced from the FDA Data Dashboard and updated monthly.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.