Servaux Safety & Ship Services

⚠️ High Risk

FEI: 3006393047 • Sandouville • FRANCE

FEI

FEI Number

3006393047

📍

Location

Sandouville

🇫🇷

Country

FRANCE

🏢

Address

Pare Des Alizes Vole Des Sarceelles, , Sandouville, , France

High Risk

FDA Import Risk Assessment

54.5

LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

Total Refusals

Unique Violations

9/14/2007

Latest Refusal

9/14/2007

Earliest Refusal

Score Breakdown

Violation Severity

71.5×40%

Refusal Volume

53.0×30%

Recency

0.0×20%

Frequency

100.0×10%

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

7525×

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).

11822×

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).

271×

DRUG GMPS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).

Refusal History

Date	Product	Violations	Division
9/14/2007	79GESBLADE, SCALPEL	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
9/14/2007	79GBSCATHETER, VENTRICULAR, GENERAL & PLASTIC SURGERY	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
9/14/2007	79KKXDRAPE, SURGICAL	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
9/14/2007	79EFQSPONGE, GAUZE	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
9/14/2007	79NADDRESSING, WOUND, OCCLUSIVE	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
9/14/2007	80KMJLUBRICANT, PATIENT	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
9/14/2007	86HPSUNIT, CRYOPHTHALMIC	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
9/14/2007	63FCP99CARDIOTONIC N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
9/14/2007	63BCP22TERBUTALINE SULFATE (BRONCHODILATOR)	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
9/14/2007	63BCQ01ALBUTEROL (BRONCHODILATOR)	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
9/14/2007	65BAR01ACETYLCYSTEINE (MUCOLYTIC)	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
9/14/2007	61XAA99ANTI-HISTAMINIC N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
9/14/2007	62FCL08CHLORHEXIDINE HCL (ANTI-INFECTIVE, TOPICAL)	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
9/14/2007	61SAJ99ANTI-ECZEMATIC N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
9/14/2007	61GCJ47SULFADIAZINE (ANTI-BACTERIAL) (NOT ANTIBIOTIC)	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
9/14/2007	62FCO08CHLORHEXIDINE HCL (ANTI-INFECTIVE, TOPICAL)	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
9/14/2007	65VCA15DIAZEPAM (SEDATIVE)	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
9/14/2007	60LAA01ACETAMINOPHEN (ANALGESIC)	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
9/14/2007	62GCP46KETOPROFEN (ANTI-INFLAMMATORY)	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
9/14/2007	63ECP19AMIODARONE HYDROCHLORIDE (CARDIAC DEPRESSANT (ANTI-ARRHYTHMIC))	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
9/14/2007	56BDF03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
9/14/2007	56BCF03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
9/14/2007	55RP55SODIUM CHLORIDE (PHARMACEUTIC NECESSITY - TONICITY AGENT)	75UNAPPROVED	New York District Office (NYK-DO)
9/14/2007	55QP70PARAFFIN	75UNAPPROVED	New York District Office (NYK-DO)
9/14/2007	55RP70BORIC ACID (PHARMACEUTIC NECESSITY)	75UNAPPROVED	New York District Office (NYK-DO)
9/14/2007	57AB07TETANUS ANTITOXIN	27DRUG GMPS	New York District Office (NYK-DO)

Frequently Asked Questions

What is Servaux Safety & Ship Services's FDA import refusal history?

Servaux Safety & Ship Services (FEI: 3006393047) has 26 FDA import refusal record(s) in our database, spanning from 9/14/2007 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. Servaux Safety & Ship Services's FEI number is 3006393047.

What types of violations has Servaux Safety & Ship Services received?

Servaux Safety & Ship Services 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 Servaux Safety & Ship Services come from?

All FDA import refusal data for Servaux Safety & Ship Services 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.