Plastimo France Sa

⚠️ Moderate Risk

FEI: 3006497274 • Lorient, Morbihan • FRANCE

FEI

FEI Number

3006497274

📍

Location

Lorient, Morbihan

🇫🇷

Country

FRANCE

🏢

Address

15 rue Ingenieur Henry Verriere, , Lorient, Morbihan, France

Moderate Risk

FDA Import Risk Assessment

35.2

LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

Total Refusals

Unique Violations

1/7/2013

Latest Refusal

12/14/2007

Earliest Refusal

Score Breakdown

Violation Severity

41.4×40%

Refusal Volume

49.0×30%

Recency

0.0×20%

Frequency

39.4×10%

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

Violation Summary

34119×

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).

5087×

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.

1182×

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).

Refusal History

Date	Product	Violations	Division
1/7/2013	79LRRKIT, FIRST AID	118NOT LISTED	Florida District Office (FLA-DO)
1/10/2011	79LRRKIT, FIRST AID	118NOT LISTED 341REGISTERED	Division of Southeast Imports (DSEI)
10/18/2010	79LRRKIT, FIRST AID	341REGISTERED	Florida District Office (FLA-DO)
10/18/2010	79LRRKIT, FIRST AID	341REGISTERED	Florida District Office (FLA-DO)
10/18/2010	79LRRKIT, FIRST AID	341REGISTERED	Florida District Office (FLA-DO)
10/18/2010	79LRRKIT, FIRST AID	341REGISTERED	Florida District Office (FLA-DO)
10/18/2010	79LRRKIT, FIRST AID	341REGISTERED	Florida District Office (FLA-DO)
10/18/2010	79LRRKIT, FIRST AID	341REGISTERED	Florida District Office (FLA-DO)
10/18/2010	79LRRKIT, FIRST AID	341REGISTERED	Florida District Office (FLA-DO)
10/18/2010	79LRRKIT, FIRST AID	341REGISTERED	Florida District Office (FLA-DO)
10/18/2010	79LRRKIT, FIRST AID	341REGISTERED	Florida District Office (FLA-DO)
10/18/2010	79LRRKIT, FIRST AID	341REGISTERED	Florida District Office (FLA-DO)
10/18/2010	79LRRKIT, FIRST AID	341REGISTERED	Florida District Office (FLA-DO)
12/14/2007	79LRRKIT, FIRST AID	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
12/14/2007	79LRRKIT, FIRST AID	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
12/14/2007	79LRRKIT, FIRST AID	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
12/14/2007	79LRRKIT, FIRST AID	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
12/14/2007	79LRRKIT, FIRST AID	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
12/14/2007	79LRRKIT, FIRST AID	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
12/14/2007	79LRRKIT, FIRST AID	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)

Frequently Asked Questions

What is Plastimo France Sa's FDA import refusal history?

Plastimo France Sa (FEI: 3006497274) has 20 FDA import refusal record(s) in our database, spanning from 12/14/2007 to 1/7/2013.

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. Plastimo France Sa's FEI number is 3006497274.

What types of violations has Plastimo France Sa received?

Plastimo France Sa has been cited for 3 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 Plastimo France Sa come from?

All FDA import refusal data for Plastimo France Sa 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.