Sharangdhar Pharma Pvt Ltd

⚠️ Moderate Risk

FEI: 3004432923 • Pune, Maharashtra • INDIA

FEI

FEI Number

3004432923

📍

Location

Pune, Maharashtra

🇮🇳

Country

INDIA

🏢

Address

91/1 Vrin Sahajeevan Soc, , Pune, Maharashtra, India

Moderate Risk

FDA Import Risk Assessment

32.9

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

8/2/2016

Latest Refusal

11/2/2009

Earliest Refusal

Score Breakdown

Violation Severity

42.3×40%

Refusal Volume

45.6×30%

Recency

0.0×20%

Frequency

23.7×10%

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

21815×

LIST INGRE

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(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.

48213×

NUTRIT LBL

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 fails to bear the required nutrition information.

23001×

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.

4881×

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.

751×

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).

Refusal History

Date	Product	Violations	Division
8/2/2016	54FGA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	75UNAPPROVED	New Orleans District Office (NOL-DO)
11/2/2009	54ABA99VITAMIN, N.E.C.	218LIST INGRE 2300DIETARYLBL	New Orleans District Office (NOL-DO)
11/2/2009	54ABA99VITAMIN, N.E.C.	218LIST INGRE 488HEALTH C	New Orleans District Office (NOL-DO)
11/2/2009	54ABA99VITAMIN, N.E.C.	218LIST INGRE 482NUTRIT LBL	New Orleans District Office (NOL-DO)
11/2/2009	54ABA99VITAMIN, N.E.C.	218LIST INGRE 482NUTRIT LBL	New Orleans District Office (NOL-DO)
11/2/2009	54ABA99VITAMIN, N.E.C.	218LIST INGRE 482NUTRIT LBL	New Orleans District Office (NOL-DO)
11/2/2009	54ABA99VITAMIN, N.E.C.	218LIST INGRE 482NUTRIT LBL	New Orleans District Office (NOL-DO)
11/2/2009	54ABA99VITAMIN, N.E.C.	218LIST INGRE 482NUTRIT LBL	New Orleans District Office (NOL-DO)
11/2/2009	54ABA99VITAMIN, N.E.C.	218LIST INGRE 482NUTRIT LBL	New Orleans District Office (NOL-DO)
11/2/2009	54ABA99VITAMIN, N.E.C.	218LIST INGRE 482NUTRIT LBL	New Orleans District Office (NOL-DO)
11/2/2009	54ABA99VITAMIN, N.E.C.	218LIST INGRE 482NUTRIT LBL	New Orleans District Office (NOL-DO)
11/2/2009	54ABA99VITAMIN, N.E.C.	218LIST INGRE 482NUTRIT LBL	New Orleans District Office (NOL-DO)
11/2/2009	54ABA99VITAMIN, N.E.C.	218LIST INGRE 482NUTRIT LBL	New Orleans District Office (NOL-DO)
11/2/2009	54ABA99VITAMIN, N.E.C.	218LIST INGRE 482NUTRIT LBL	New Orleans District Office (NOL-DO)
11/2/2009	54ABA99VITAMIN, N.E.C.	218LIST INGRE 482NUTRIT LBL	New Orleans District Office (NOL-DO)
11/2/2009	54ABA99VITAMIN, N.E.C.	218LIST INGRE 482NUTRIT LBL	New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Sharangdhar Pharma Pvt Ltd's FDA import refusal history?

Sharangdhar Pharma Pvt Ltd (FEI: 3004432923) has 16 FDA import refusal record(s) in our database, spanning from 11/2/2009 to 8/2/2016.

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. Sharangdhar Pharma Pvt Ltd's FEI number is 3004432923.

What types of violations has Sharangdhar Pharma Pvt Ltd received?

Sharangdhar Pharma Pvt Ltd 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 Sharangdhar Pharma Pvt Ltd come from?

All FDA import refusal data for Sharangdhar Pharma 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.