ImportRefusal LogoImportRefusal

Pfizer Free Zone Panama

⚠️ High Risk

FEI: 3009204588 • Colon • PANAMA

FEI

FEI Number

3009204588

📍

Location

Colon

🇵🇦

Country

PANAMA
🏢

Address

Colon Free Zonemit Logistics Park, , Colon, , Panama

High Risk

FDA Import Risk Assessment

50.7
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

6
Total Refusals
2
Unique Violations
10/23/2012
Latest Refusal
10/23/2012
Earliest Refusal

Score Breakdown

Violation Severity
88.3×40%
Refusal Volume
31.3×30%
Recency
0.0×20%
Frequency
60.0×10%
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

755×

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).

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
10/23/2012
55RP99PHARMACEUTIC NECESSITIES, N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
10/23/2012
55RP99PHARMACEUTIC NECESSITIES, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
10/23/2012
55RP99PHARMACEUTIC NECESSITIES, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
10/23/2012
55RP99PHARMACEUTIC NECESSITIES, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
10/23/2012
55RP99PHARMACEUTIC NECESSITIES, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
10/23/2012
55RP99PHARMACEUTIC NECESSITIES, N.E.C.
27DRUG GMPS
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Pfizer Free Zone Panama's FDA import refusal history?

Pfizer Free Zone Panama (FEI: 3009204588) has 6 FDA import refusal record(s) in our database, spanning from 10/23/2012 to 10/23/2012.

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. Pfizer Free Zone Panama's FEI number is 3009204588.

What types of violations has Pfizer Free Zone Panama received?

Pfizer Free Zone Panama 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 Pfizer Free Zone Panama come from?

All FDA import refusal data for Pfizer Free Zone Panama 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.