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Anicare Pharmaceuticals Pvt Ltd.

⚠️ Moderate Risk

FEI: 3007450508 • Navi Mumbai, Maharashtra • INDIA

FEI

FEI Number

3007450508

📍

Location

Navi Mumbai, Maharashtra

🇮🇳

Country

INDIA
🏢

Address

Plot No. A-143 / 5 & 6, Ttc Ind. Area, Khairne M.I.D.C, Thane-Belapur Rd, Behind Midc Fire Station, Navi Mumbai, Maharashtra, India

Moderate Risk

FDA Import Risk Assessment

47.4
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
10/13/2023
Latest Refusal
10/13/2023
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
11.2×30%
Recency
55.1×20%
Frequency
10.0×10%
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

© ImportRefusal.com Original Analysis

Violation Summary

271×

DRUG GMPS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).

Refusal History

DateProductViolationsDivision
10/13/2023
56YBJ99ANTIBIOTIC N.E.C.
27DRUG GMPS
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is Anicare Pharmaceuticals Pvt Ltd.'s FDA import refusal history?

Anicare Pharmaceuticals Pvt Ltd. (FEI: 3007450508) has 1 FDA import refusal record(s) in our database, spanning from 10/13/2023 to 10/13/2023.

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. Anicare Pharmaceuticals Pvt Ltd.'s FEI number is 3007450508.

What types of violations has Anicare Pharmaceuticals Pvt Ltd. received?

Anicare Pharmaceuticals 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 Anicare Pharmaceuticals Pvt Ltd. come from?

All FDA import refusal data for Anicare Pharmaceuticals 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.