Granules India Private Ltd

⚠️ Moderate Risk

FEI: 3003605341 • Hyderabad • INDIA

FEI

FEI Number

3003605341

📍

Location

Hyderabad

🇮🇳

Country

INDIA

🏢

Address

2 A Usha Towers, , Hyderabad, , India

Moderate Risk

FDA Import Risk Assessment

42.9

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

2/27/2006

Latest Refusal

8/5/2004

Earliest Refusal

Score Breakdown

Violation Severity

62.3×40%

Refusal Volume

38.6×30%

Recency

0.0×20%

Frequency

63.9×10%

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

1186×

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).

166×

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.

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
2/27/2006	60LBF01ACETAMINOPHEN (ANALGESIC)	118NOT LISTED 16DIRECTIONS	New York District Office (NYK-DO)
2/27/2006	60LDY82PHENAZOPYRIDINE HCL (ANALGESIC)	75UNAPPROVED	New York District Office (NYK-DO)
2/27/2006	60LAS01ACETAMINOPHEN (ANALGESIC)	16DIRECTIONS	New York District Office (NYK-DO)
2/17/2006	60LDY82PHENAZOPYRIDINE HCL (ANALGESIC)	118NOT LISTED 16DIRECTIONS	New York District Office (NYK-DO)
11/18/2004	61PIR55METFORMIN HCL (ANTI-DIABETIC)	118NOT LISTED 16DIRECTIONS	New York District Office (NYK-DO)
11/18/2004	60LAS01ACETAMINOPHEN (ANALGESIC)	118NOT LISTED	New York District Office (NYK-DO)
11/18/2004	60LAS01ACETAMINOPHEN (ANALGESIC)	118NOT LISTED	New York District Office (NYK-DO)
11/18/2004	64HBS02GUAIFENESIN (EXPECTORANT)	118NOT LISTED	New York District Office (NYK-DO)
9/9/2004	60LIS01ACETAMINOPHEN (ANALGESIC)	16DIRECTIONS	New York District Office (NYK-DO)
8/5/2004	61HDY29METHENAMINE (ANTI-BACTERIAL)	16DIRECTIONS	New York District Office (NYK-DO)

Frequently Asked Questions

What is Granules India Private Ltd's FDA import refusal history?

Granules India Private Ltd (FEI: 3003605341) has 10 FDA import refusal record(s) in our database, spanning from 8/5/2004 to 2/27/2006.

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. Granules India Private Ltd's FEI number is 3003605341.

What types of violations has Granules India Private Ltd received?

Granules India Private 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 Granules India Private Ltd come from?

All FDA import refusal data for Granules India Private 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.