MSD International GmbH (Puerto Rico Branch) LLC
⚠️ Moderate Risk
FEI: 2650155 • Las Piedras, PR • UNITED STATES
FEI Number
2650155
Location
Las Piedras, PR
Country
UNITED STATESAddress
Pridco Indus Park, Sr 183, Las Piedras, PR, United States
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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).
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).
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/24/2016 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 3/24/2016 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 11/24/2014 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 11/24/2014 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 11/24/2014 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 12/13/2011 | 61JCA15EZETIMIBE | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/8/2009 | 61JCA15EZETIMIBE | San Francisco District Office (SAN-DO) | |
| 3/29/2005 | 62FBC56ENFUVIRTIDE | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is MSD International GmbH (Puerto Rico Branch) LLC's FDA import refusal history?
MSD International GmbH (Puerto Rico Branch) LLC (FEI: 2650155) has 8 FDA import refusal record(s) in our database, spanning from 3/29/2005 to 3/24/2016.
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. MSD International GmbH (Puerto Rico Branch) LLC's FEI number is 2650155.
What types of violations has MSD International GmbH (Puerto Rico Branch) LLC received?
MSD International GmbH (Puerto Rico Branch) LLC has been cited for 3 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 MSD International GmbH (Puerto Rico Branch) LLC come from?
All FDA import refusal data for MSD International GmbH (Puerto Rico Branch) LLC 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.