Phytotech Extracts Pvt. Ltd.

⚠️ Moderate Risk

FEI: 3013239323 • Bengaluru, Karnataka • INDIA

FEI

FEI Number

3013239323

📍

Location

Bengaluru, Karnataka

🇮🇳

Country

INDIA

🏢

Address

Sri Krishna Nagar, #103/103 Kannur Post; 1st Floor; Hennur Bagalur Main Road, Bengaluru, Karnataka, India

Moderate Risk

FDA Import Risk Assessment

41.1

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

3/8/2018

Latest Refusal

3/8/2018

Earliest Refusal

Score Breakdown

Violation Severity

64.2×40%

Refusal Volume

31.3×30%

Recency

0.0×20%

Frequency

60.0×10%

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

4735×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

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).

163×

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.

Refusal History

Date	Product	Violations	Division
3/8/2018	66YAY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.	473LABELING 75UNAPPROVED	Division of Northeast Imports (DNEI)
3/8/2018	31AVT99COFFEE, N.E.C.	473LABELING	Division of Northeast Imports (DNEI)
3/8/2018	31AVT99COFFEE, N.E.C.	473LABELING	Division of Northeast Imports (DNEI)
3/8/2018	66YAY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.	16DIRECTIONS 473LABELING 75UNAPPROVED	Division of Northeast Imports (DNEI)
3/8/2018	66YAY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.	16DIRECTIONS 473LABELING 75UNAPPROVED	Division of Northeast Imports (DNEI)
3/8/2018	66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.	16DIRECTIONS 75UNAPPROVED	Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is Phytotech Extracts Pvt. Ltd.'s FDA import refusal history?

Phytotech Extracts Pvt. Ltd. (FEI: 3013239323) has 6 FDA import refusal record(s) in our database, spanning from 3/8/2018 to 3/8/2018.

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. Phytotech Extracts Pvt. Ltd.'s FEI number is 3013239323.

What types of violations has Phytotech Extracts Pvt. Ltd. received?

Phytotech Extracts Pvt. Ltd. has been cited for 3 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 Phytotech Extracts Pvt. Ltd. come from?

All FDA import refusal data for Phytotech Extracts 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.