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Pharmatech

⚠️ Moderate Risk

FEI: 3009035315 • D.n., Distrito Nacional • DOMINICAN REPUBLIC

FEI

FEI Number

3009035315

📍

Location

D.n., Distrito Nacional

🇩🇴
🏢

Address

C Jose Desiderio Valverde 103, , Santo Domingo, D.n., Distrito Nacional, Dominican Republic

Moderate Risk

FDA Import Risk Assessment

35.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
2
Unique Violations
6/26/2014
Latest Refusal
6/23/2014
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

1183×

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).

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
6/26/2014
64LAK61TRIAMCINOLONE ACETONIDE (GLUCOCORTICOID)
118NOT LISTED
San Juan District Office (SJN-DO)
6/26/2014
61LAK29ENOXAPARIN SODIUM (ANTI-COAGULANT)
118NOT LISTED
San Juan District Office (SJN-DO)
6/23/2014
64LAK61TRIAMCINOLONE ACETONIDE (GLUCOCORTICOID)
118NOT LISTED
San Juan District Office (SJN-DO)
6/23/2014
61LAK29ENOXAPARIN SODIUM (ANTI-COAGULANT)
75UNAPPROVED
San Juan District Office (SJN-DO)

Frequently Asked Questions

What is Pharmatech's FDA import refusal history?

Pharmatech (FEI: 3009035315) has 4 FDA import refusal record(s) in our database, spanning from 6/23/2014 to 6/26/2014.

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. Pharmatech's FEI number is 3009035315.

What types of violations has Pharmatech received?

Pharmatech 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 Pharmatech come from?

All FDA import refusal data for Pharmatech 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.