Juana Hernandez Alonzo

⚠️ Moderate Risk

FEI: 3009076332 • Guatemala, Guatemala • GUATEMALA

FEI

FEI Number

3009076332

📍

Location

Guatemala, Guatemala

🇬🇹

Country

GUATEMALA

🏢

Address

Cajero El Socorrocoutepeque z. 1, , Guatemala, Guatemala, Guatemala

Moderate Risk

FDA Import Risk Assessment

43.6

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

9/9/2011

Latest Refusal

9/9/2011

Earliest Refusal

Score Breakdown

Violation Severity

75.0×40%

Refusal Volume

28.8×30%

Recency

0.0×20%

Frequency

50.0×10%

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

754×

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).

273×

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).

1181×

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).

3411×

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).

5081×

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.

Refusal History

Date	Product	Violations	Division
9/9/2011	65JCK31PROGESTERONE (PROGESTIN)	27DRUG GMPS 75UNAPPROVED	Cincinnati District Office (CIN-DO)
9/9/2011	66VCK99MISCELLANEOUS PATENT MEDICINES, ETC.	27DRUG GMPS 75UNAPPROVED	Cincinnati District Office (CIN-DO)
9/9/2011	66VDK99MISCELLANEOUS PATENT MEDICINES, ETC.	27DRUG GMPS 75UNAPPROVED	Cincinnati District Office (CIN-DO)
9/9/2011	74DQFACTUATOR, SYRINGE, INJECTOR TYPE	118NOT LISTED 341REGISTERED 508NO 510(K)	Cincinnati District Office (CIN-DO)
9/9/2011	66VCK99MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED	Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Juana Hernandez Alonzo's FDA import refusal history?

Juana Hernandez Alonzo (FEI: 3009076332) has 5 FDA import refusal record(s) in our database, spanning from 9/9/2011 to 9/9/2011.

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. Juana Hernandez Alonzo's FEI number is 3009076332.

What types of violations has Juana Hernandez Alonzo received?

Juana Hernandez Alonzo has been cited for 5 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 Juana Hernandez Alonzo come from?

All FDA import refusal data for Juana Hernandez Alonzo 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.