PT KARUNIA PENYEMBUHAN ALAMI

⚠️ Moderate Risk

FEI: 3027543380 • Bandung, Jawa Barat • INDONESIA

FEI

FEI Number

3027543380

📍

Location

Bandung, Jawa Barat

🇮🇩

Country

INDONESIA

🏢

Address

Jln. Tirtasari No 21, , Bandung, Jawa Barat, Indonesia

Moderate Risk

FDA Import Risk Assessment

48.6

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

11/14/2023

Latest Refusal

11/14/2023

Earliest Refusal

Score Breakdown

Violation Severity

50.0×40%

Refusal Volume

37.0×30%

Recency

42.6×20%

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

23009×

DIETARYLBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.

4889×

HEALTH C

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.

Refusal History

Date	Product	Violations	Division
11/14/2023	21TYH15MANGOSTEEN, DRIED OR PASTE	2300DIETARYLBL 488HEALTH C	Division of Southeast Imports (DSEI)
11/14/2023	54KBT10MORINGA OLEIFERA (HERBAL AND BOTANICAL (NOT TEAS II) CONTD	2300DIETARYLBL 488HEALTH C	Division of Southeast Imports (DSEI)
11/14/2023	28CYH19GINGER, NATURAL EXTRACT OR FLAVOR (SPICE)	2300DIETARYLBL 488HEALTH C	Division of Southeast Imports (DSEI)
11/14/2023	21TYH06PAPAYA, DRIED OR PASTE	2300DIETARYLBL 488HEALTH C	Division of Southeast Imports (DSEI)
11/14/2023	24UYH25SPINACH, DRIED OR PASTE	2300DIETARYLBL 488HEALTH C	Division of Southeast Imports (DSEI)
11/14/2023	54JBY22TURMERIC (HERBAL & BOTANICALS II)	2300DIETARYLBL 488HEALTH C	Division of Southeast Imports (DSEI)
11/14/2023	54FBT93NONI (HERBAL & BOTANICALS, NOT TEAS)	2300DIETARYLBL 488HEALTH C	Division of Southeast Imports (DSEI)
11/14/2023	54YCY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.	2300DIETARYLBL 488HEALTH C	Division of Southeast Imports (DSEI)
11/14/2023	54YBY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.	2300DIETARYLBL 488HEALTH C	Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is PT KARUNIA PENYEMBUHAN ALAMI's FDA import refusal history?

PT KARUNIA PENYEMBUHAN ALAMI (FEI: 3027543380) has 9 FDA import refusal record(s) in our database, spanning from 11/14/2023 to 11/14/2023.

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. PT KARUNIA PENYEMBUHAN ALAMI's FEI number is 3027543380.

What types of violations has PT KARUNIA PENYEMBUHAN ALAMI received?

PT KARUNIA PENYEMBUHAN ALAMI 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 PT KARUNIA PENYEMBUHAN ALAMI come from?

All FDA import refusal data for PT KARUNIA PENYEMBUHAN ALAMI 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.