Newlife Herbs Manufacturing (Pvt) Ltd

⚠️ Moderate Risk

FEI: 3009186648 • Peradeniya, Kandy • SRI LANKA

FEI

FEI Number

3009186648

📍

Location

Peradeniya, Kandy

🇱🇰

Country

SRI LANKA

🏢

Address

300/3 Pahala Eriyagama, , Peradeniya, Kandy, Sri Lanka

Moderate Risk

FDA Import Risk Assessment

42.7

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

4/11/2012

Latest Refusal

4/11/2012

Earliest Refusal

Score Breakdown

Violation Severity

50.0×40%

Refusal Volume

42.5×30%

Recency

0.0×20%

Frequency

100.0×10%

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

26013×

FALSE

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.

Refusal History

Date	Product	Violations	Division
4/11/2012	31KFH01TEA, BLACK	260FALSE	Los Angeles District Office (LOS-DO)
4/11/2012	31KFH02TEA, GREEN	260FALSE	Los Angeles District Office (LOS-DO)
4/11/2012	54EFT99HERBALS & BOTANICAL TEAS, N.E.C.	260FALSE	Los Angeles District Office (LOS-DO)
4/11/2012	54EFT99HERBALS & BOTANICAL TEAS, N.E.C.	260FALSE	Los Angeles District Office (LOS-DO)
4/11/2012	54EFT99HERBALS & BOTANICAL TEAS, N.E.C.	260FALSE	Los Angeles District Office (LOS-DO)
4/11/2012	54EFT99HERBALS & BOTANICAL TEAS, N.E.C.	260FALSE	Los Angeles District Office (LOS-DO)
4/11/2012	54EFT99HERBALS & BOTANICAL TEAS, N.E.C.	260FALSE	Los Angeles District Office (LOS-DO)
4/11/2012	54EFT99HERBALS & BOTANICAL TEAS, N.E.C.	260FALSE	Los Angeles District Office (LOS-DO)
4/11/2012	54EFT99HERBALS & BOTANICAL TEAS, N.E.C.	260FALSE	Los Angeles District Office (LOS-DO)
4/11/2012	54EFT99HERBALS & BOTANICAL TEAS, N.E.C.	260FALSE	Los Angeles District Office (LOS-DO)
4/11/2012	54EFT99HERBALS & BOTANICAL TEAS, N.E.C.	260FALSE	Los Angeles District Office (LOS-DO)
4/11/2012	54EFT99HERBALS & BOTANICAL TEAS, N.E.C.	260FALSE	Los Angeles District Office (LOS-DO)
4/11/2012	54EFT99HERBALS & BOTANICAL TEAS, N.E.C.	260FALSE	Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Newlife Herbs Manufacturing (Pvt) Ltd's FDA import refusal history?

Newlife Herbs Manufacturing (Pvt) Ltd (FEI: 3009186648) has 13 FDA import refusal record(s) in our database, spanning from 4/11/2012 to 4/11/2012.

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. Newlife Herbs Manufacturing (Pvt) Ltd's FEI number is 3009186648.

What types of violations has Newlife Herbs Manufacturing (Pvt) Ltd received?

Newlife Herbs Manufacturing (Pvt) Ltd has been cited for 1 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 Newlife Herbs Manufacturing (Pvt) Ltd come from?

All FDA import refusal data for Newlife Herbs Manufacturing (Pvt) Ltd 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.