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Royste, S. A.

⚠️ Moderate Risk

FEI: 3007929272 • Santo Domingo Este, Santo Domingo • DOMINICAN REPUBLIC

FEI

FEI Number

3007929272

📍

Location

Santo Domingo Este, Santo Domingo

🇩🇴
🏢

Address

Calle 2da, No. 64a Urb. Isabel 2da., Santo Domingo Este, Santo Domingo, Dominican Republic

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
4/7/2020
Latest Refusal
4/7/2020
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

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
4/7/2020
66VDJ99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Royste, S. A.'s FDA import refusal history?

Royste, S. A. (FEI: 3007929272) has 1 FDA import refusal record(s) in our database, spanning from 4/7/2020 to 4/7/2020.

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. Royste, S. A.'s FEI number is 3007929272.

What types of violations has Royste, S. A. received?

Royste, S. A. has been cited for 1 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 Royste, S. A. come from?

All FDA import refusal data for Royste, S. A. 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.