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FARMAPRIM

⚠️ Moderate Risk

FEI: 3012838935 • Chisinau, Chisinau • MOLDOVA

FEI

FEI Number

3012838935

📍

Location

Chisinau, Chisinau

🇲🇩

Country

MOLDOVA
🏢

Address

Crinilor 5, , Chisinau, Chisinau, Moldova

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
11/15/2016
Latest Refusal
11/15/2016
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
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

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

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

DateProductViolationsDivision
11/15/2016
60LCM99ANALGESIC, N.E.C.
3280FRNMFGREG
75UNAPPROVED
New York District Office (NYK-DO)

Frequently Asked Questions

What is FARMAPRIM's FDA import refusal history?

FARMAPRIM (FEI: 3012838935) has 1 FDA import refusal record(s) in our database, spanning from 11/15/2016 to 11/15/2016.

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. FARMAPRIM's FEI number is 3012838935.

What types of violations has FARMAPRIM received?

FARMAPRIM has been cited for 2 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 FARMAPRIM come from?

All FDA import refusal data for FARMAPRIM 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.