Dabi Atlante Sa Inds.

⚠️ Moderate Risk

FEI: 3003478608 • Ribeirao Preto • BRAZIL

FEI

FEI Number

3003478608

📍

Location

Ribeirao Preto

🇧🇷

Country

BRAZIL

🏢

Address

Av.Presidente Castelo Branco, , Ribeirao Preto, , Brazil

Moderate Risk

FDA Import Risk Assessment

40.4

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

7/19/2004

Latest Refusal

5/2/2002

Earliest Refusal

Score Breakdown

Violation Severity

50.5×40%

Refusal Volume

44.6×30%

Recency

0.0×20%

Frequency

67.7×10%

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

34113×

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).

11812×

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).

50812×

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.

472×

NON STD

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.

Refusal History

Date	Product	Violations	Division
7/19/2004	76KLCCHAIR WITH UNIT	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
7/19/2004	76EHDUNIT, X-RAY, EXTRAORAL WITH TIMER	47NON STD	Division of Southeast Imports (DSEI)
7/19/2004	76EHDUNIT, X-RAY, EXTRAORAL WITH TIMER	47NON STD	Division of Southeast Imports (DSEI)
9/22/2003	76EHDUNIT, X-RAY, EXTRAORAL WITH TIMER	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
9/22/2003	76KLCCHAIR WITH UNIT	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
9/22/2003	76EHDUNIT, X-RAY, EXTRAORAL WITH TIMER	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
7/25/2003	76EHDUNIT, X-RAY, EXTRAORAL WITH TIMER	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
7/25/2003	76KLCCHAIR WITH UNIT	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
7/25/2003	76EHDUNIT, X-RAY, EXTRAORAL WITH TIMER	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
7/25/2003	76EJBHANDLE, INSTRUMENT, DENTAL	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
10/2/2002	76EHDUNIT, X-RAY, EXTRAORAL WITH TIMER	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
10/2/2002	76KLCCHAIR WITH UNIT	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
10/2/2002	76EHDUNIT, X-RAY, EXTRAORAL WITH TIMER	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
10/2/2002	76EJBHANDLE, INSTRUMENT, DENTAL	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
5/2/2002	74DSFRECORDER, PAPER CHART	118NOT LISTED 341REGISTERED	Florida District Office (FLA-DO)

Frequently Asked Questions

What is Dabi Atlante Sa Inds.'s FDA import refusal history?

Dabi Atlante Sa Inds. (FEI: 3003478608) has 15 FDA import refusal record(s) in our database, spanning from 5/2/2002 to 7/19/2004.

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. Dabi Atlante Sa Inds.'s FEI number is 3003478608.

What types of violations has Dabi Atlante Sa Inds. received?

Dabi Atlante Sa Inds. has been cited for 4 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 Dabi Atlante Sa Inds. come from?

All FDA import refusal data for Dabi Atlante Sa Inds. 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.