Dr Daniel Germano Carlos

⚠️ Moderate Risk

FEI: 3004364911 • Aguavalva • PORTUGAL

FEI

FEI Number

3004364911

📍

Location

Aguavalva

🇵🇹

Country

PORTUGAL

🏢

Address

Rua Joao Martins Da Fonseca, , Aguavalva, , Portugal

Moderate Risk

FDA Import Risk Assessment

48.1

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

2/19/2004

Latest Refusal

2/19/2004

Earliest Refusal

Score Breakdown

Violation Severity

70.0×40%

Refusal Volume

37.0×30%

Recency

0.0×20%

Frequency

90.0×10%

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

1189×

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).

759×

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).

Refusal History

Date	Product	Violations	Division
2/19/2004	61TDB29SCOPOLAMINE (ANTI-EMETIC/NAUSEANT)	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
2/19/2004	61XCB99ANTI-HISTAMINIC N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
2/19/2004	64LCJ37HYDROCORTISONE (GLUCOCORTICOID)	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
2/19/2004	66MCA60THIORIDAZINE (TRANQUILIZER)	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
2/19/2004	60LAA01ACETAMINOPHEN (ANALGESIC)	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
2/19/2004	62GAA41IBUPROFEN (ANTI-INFLAMMATORY)	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
2/19/2004	62GCJ18DICLOFENAC SODIUM (ANTI-INFLAMMATORY)	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
2/19/2004	56DDA49NEOMYCIN, N.E.C. (AMINOGLYCOSIDES)	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
2/19/2004	56BCE03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)

Frequently Asked Questions

What is Dr Daniel Germano Carlos's FDA import refusal history?

Dr Daniel Germano Carlos (FEI: 3004364911) has 9 FDA import refusal record(s) in our database, spanning from 2/19/2004 to 2/19/2004.

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. Dr Daniel Germano Carlos's FEI number is 3004364911.

What types of violations has Dr Daniel Germano Carlos received?

Dr Daniel Germano Carlos has been cited for 2 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 Dr Daniel Germano Carlos come from?

All FDA import refusal data for Dr Daniel Germano Carlos 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.