Fanem Ltda

⚠️ Moderate Risk

FEI: 3000315977 • Sao Paulo, Sao Paulo • BRAZIL

FEI

FEI Number

3000315977

📍

Location

Sao Paulo, Sao Paulo

🇧🇷

Country

BRAZIL

🏢

Address

Avenida General Ataliba Leonel, 1790, , Sao Paulo, Sao Paulo, Brazil

Moderate Risk

FDA Import Risk Assessment

38.3

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

1/15/2021

Latest Refusal

3/27/2002

Earliest Refusal

Score Breakdown

Violation Severity

48.4×40%

Refusal Volume

57.2×30%

Recency

0.0×20%

Frequency

18.1×10%

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

34126×

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).

50821×

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.

11817×

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
1/15/2021	80PEQACCESSORIES TO EXAMINATION LIGHT	118NOT LISTED	Division of Southeast Imports (DSEI)
1/15/2021	80FMZINCUBATOR, NEONATAL	118NOT LISTED	Division of Southeast Imports (DSEI)
8/14/2013	80ONMRADIANT INFANT WARMER CABINET	118NOT LISTED 341REGISTERED	Florida District Office (FLA-DO)
1/15/2013	80KZFDEVICE, MEDICAL EXAMINATION, AC POWERED	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
8/6/2012	73NHKRESUSCITATOR, MANUAL, NON SELF-INFLATING	118NOT LISTED 341REGISTERED	Florida District Office (FLA-DO)
8/6/2012	80NZGBASSINET, HOSPITAL	118NOT LISTED 341REGISTERED	Florida District Office (FLA-DO)
8/6/2012	80LBIUNIT, NEONATAL PHOTOTHERAPY	118NOT LISTED 341REGISTERED	Florida District Office (FLA-DO)
8/6/2012	80ONMRADIANT INFANT WARMER CABINET	118NOT LISTED 341REGISTERED	Florida District Office (FLA-DO)
8/6/2012	80FPLINCUBATOR, NEONATAL TRANSPORT	118NOT LISTED 341REGISTERED	Florida District Office (FLA-DO)
2/16/2010	89NIWLAMP, INFRARED, PREVENTION	118NOT LISTED	Florida District Office (FLA-DO)
2/16/2010	89NIWLAMP, INFRARED, PREVENTION	118NOT LISTED	Florida District Office (FLA-DO)
3/3/2009	80FMZINCUBATOR, NEONATAL	118NOT LISTED	Division of Southeast Imports (DSEI)
3/3/2009	80FMZINCUBATOR, NEONATAL	118NOT LISTED	Division of Southeast Imports (DSEI)
1/18/2008	80FMZINCUBATOR, NEONATAL	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
12/22/2006	80FLESTERILIZER, STEAM	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
8/24/2006	80FMSBED, PEDIATRIC OPEN HOSPITAL	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
12/22/2005	80FMZINCUBATOR, NEONATAL	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
6/22/2005	80FMZINCUBATOR, NEONATAL	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
4/22/2005	80FMSBED, PEDIATRIC OPEN HOSPITAL	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
10/7/2004	84MWTTHERAPEUTIC NEUROLOGY DEVICE, MAGNET	118NOT LISTED 341REGISTERED	Florida District Office (FLA-DO)
9/10/2004	80MMKCONTAINER, SHARPS	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
6/22/2004	74DRTMONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
6/22/2004	83JTQBATH, INCUBATORS/WATER, ALL	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
6/22/2004	73KGBMASK, OXYGEN, NON-REBREATHING	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
6/22/2004	80LBIUNIT, NEONATAL PHOTOTHERAPY	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
6/22/2004	80FMSBED, PEDIATRIC OPEN HOSPITAL	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
6/7/2004	80LDQDEVICE, GENERAL MEDICAL	508NO 510(K)	Florida District Office (FLA-DO)
9/2/2003	80LGXTABLE, EXAMINATION, MEDICAL, POWERED	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
9/2/2003	89ILKTRANSPORT, PATIENT, POWERED	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
9/2/2003	80LGNCHAMBER, PATIENT TRANSPORT ISOLATION	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
7/15/2003	80FMSBED, PEDIATRIC OPEN HOSPITAL	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
7/15/2003	80FPLINCUBATOR, NEONATAL TRANSPORT	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
4/30/2003	80FPLINCUBATOR, NEONATAL TRANSPORT	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
3/27/2002	80FMZINCUBATOR, NEONATAL	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)

Frequently Asked Questions

What is Fanem Ltda's FDA import refusal history?

Fanem Ltda (FEI: 3000315977) has 34 FDA import refusal record(s) in our database, spanning from 3/27/2002 to 1/15/2021.

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. Fanem Ltda's FEI number is 3000315977.

What types of violations has Fanem Ltda received?

Fanem Ltda 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 Fanem Ltda come from?

All FDA import refusal data for Fanem Ltda 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.