LABORATORIOS ALPHA NATURA SAC

⚠️ Moderate Risk

FEI: 3011601444 • San Isidro, Lima • PERU

FEI

FEI Number

3011601444

📍

Location

San Isidro, Lima

🇵🇪

Country

PERU

🏢

Address

Av. Las Camelias # 725 Piso 8vo., , San Isidro, Lima, Peru

Moderate Risk

FDA Import Risk Assessment

47.2

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

10/19/2015

Latest Refusal

10/19/2015

Earliest Refusal

Score Breakdown

Violation Severity

75.3×40%

Refusal Volume

33.5×30%

Recency

0.0×20%

Frequency

70.0×10%

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

757×

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).

164×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

1182×

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).

22802×

DIRSEXMPT

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.

Refusal History

Date	Product	Violations	Division
10/19/2015	54FBE99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	118NOT LISTED 2280DIRSEXMPT 75UNAPPROVED	Los Angeles District Office (LOS-DO)
10/19/2015	54FBE99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	118NOT LISTED 2280DIRSEXMPT 75UNAPPROVED	Los Angeles District Office (LOS-DO)
10/19/2015	54FBE99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	75UNAPPROVED	Los Angeles District Office (LOS-DO)
10/19/2015	54FBE99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	16DIRECTIONS 75UNAPPROVED	Los Angeles District Office (LOS-DO)
10/19/2015	54FBE99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	16DIRECTIONS 75UNAPPROVED	Los Angeles District Office (LOS-DO)
10/19/2015	54FBE99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	16DIRECTIONS 75UNAPPROVED	Los Angeles District Office (LOS-DO)
10/19/2015	54FBE99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	16DIRECTIONS 75UNAPPROVED	Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is LABORATORIOS ALPHA NATURA SAC's FDA import refusal history?

LABORATORIOS ALPHA NATURA SAC (FEI: 3011601444) has 7 FDA import refusal record(s) in our database, spanning from 10/19/2015 to 10/19/2015.

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. LABORATORIOS ALPHA NATURA SAC's FEI number is 3011601444.

What types of violations has LABORATORIOS ALPHA NATURA SAC received?

LABORATORIOS ALPHA NATURA SAC 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 LABORATORIOS ALPHA NATURA SAC come from?

All FDA import refusal data for LABORATORIOS ALPHA NATURA SAC 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.