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Neo Bioloab

⚠️ High Risk

FEI: 3011373559 • Woburn, MA • UNITED STATES

FEI

FEI Number

3011373559

📍

Location

Woburn, MA

🇺🇸
🏢

Address

395 W Cummings Park, , Woburn, MA, United States

High Risk

FDA Import Risk Assessment

60.9
LowModerateHighCritical

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

Statistics

26
Total Refusals
2
Unique Violations
11/9/2015
Latest Refusal
11/9/2015
Earliest Refusal

Score Breakdown

Violation Severity
87.4×40%
Refusal Volume
53.0×30%
Recency
0.0×20%
Frequency
100.0×10%
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

7526×

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).

3331×

LACKS FIRM

The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.

Refusal History

DateProductViolationsDivision
11/9/2015
64RCP99HORMONE N.E.C.
333LACKS FIRM
75UNAPPROVED
New Orleans District Office (NOL-DO)
11/9/2015
64RCP99HORMONE N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
11/9/2015
64RCP99HORMONE N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
11/9/2015
64RCP99HORMONE N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
11/9/2015
64RCP99HORMONE N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
11/9/2015
64RCP99HORMONE N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
11/9/2015
64RCP99HORMONE N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
11/9/2015
64RCP99HORMONE N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
11/9/2015
64RCP99HORMONE N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
11/9/2015
64RCP99HORMONE N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
11/9/2015
64RCP99HORMONE N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
11/9/2015
64RCP99HORMONE N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
11/9/2015
64RCP99HORMONE N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
11/9/2015
64RCP99HORMONE N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
11/9/2015
64RCP99HORMONE N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
11/9/2015
64RCP99HORMONE N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
11/9/2015
64RCP99HORMONE N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
11/9/2015
64RDP99HORMONE N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
11/9/2015
64RCP99HORMONE N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
11/9/2015
64RCP99HORMONE N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
11/9/2015
64RCP99HORMONE N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
11/9/2015
64RCP99HORMONE N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
11/9/2015
64RCP99HORMONE N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
11/9/2015
65DCP06OXYTOCIN (INJECTION) (OXYTOCIC)
75UNAPPROVED
New Orleans District Office (NOL-DO)
11/9/2015
64RCP99HORMONE N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
11/9/2015
56FIP99PEPTIDE N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Neo Bioloab's FDA import refusal history?

Neo Bioloab (FEI: 3011373559) has 26 FDA import refusal record(s) in our database, spanning from 11/9/2015 to 11/9/2015.

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. Neo Bioloab's FEI number is 3011373559.

What types of violations has Neo Bioloab received?

Neo Bioloab 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 Neo Bioloab come from?

All FDA import refusal data for Neo Bioloab 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.