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BRYWOOD PHARMACEUTICAL LTD PAR

⚠️ Moderate Risk

FEI: 3003031331 • BANGKOK • THAILAND

FEI

FEI Number

3003031331

📍

Location

BANGKOK

🇹🇭

Country

THAILAND
🏢

Address

313 SUKSAWAN, 7 SUSKAWAN ROAD, BANGKOK, , Thailand

Moderate Risk

FDA Import Risk Assessment

31.4
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
12/13/2013
Latest Refusal
11/4/2009
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
7.3×10%
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
12/13/2013
66V99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
San Francisco District Office (SAN-DO)
12/13/2013
66V99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
San Francisco District Office (SAN-DO)
11/4/2009
54ECL99HERBALS & BOTANICAL TEAS, N.E.C.
118NOT LISTED
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is BRYWOOD PHARMACEUTICAL LTD PAR's FDA import refusal history?

BRYWOOD PHARMACEUTICAL LTD PAR (FEI: 3003031331) has 3 FDA import refusal record(s) in our database, spanning from 11/4/2009 to 12/13/2013.

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. BRYWOOD PHARMACEUTICAL LTD PAR's FEI number is 3003031331.

What types of violations has BRYWOOD PHARMACEUTICAL LTD PAR received?

BRYWOOD PHARMACEUTICAL LTD PAR 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 BRYWOOD PHARMACEUTICAL LTD PAR come from?

All FDA import refusal data for BRYWOOD PHARMACEUTICAL LTD PAR 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.