Patheon Manufacturing Services LLC
⚠️ Moderate Risk
FEI: 1018495 • Greenville, NC • UNITED STATES
FEI Number
1018495
Location
Greenville, NC
Country
UNITED STATESAddress
5900 Martin Luther King Jr Hwy, , Greenville, NC, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/2/2020 | 66YIP99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 7/19/2016 | 64OCY03ECULIZUMAB, MONOCLONAL ANTIBODIES | 118NOT LISTED | Florida District Office (FLA-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) |
| 8/10/2012 | 62ICB30MERCAPTOPURINE (ANTI-NEOPLASTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Patheon Manufacturing Services LLC's FDA import refusal history?
Patheon Manufacturing Services LLC (FEI: 1018495) has 5 FDA import refusal record(s) in our database, spanning from 8/10/2012 to 9/2/2020.
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. Patheon Manufacturing Services LLC's FEI number is 1018495.
What types of violations has Patheon Manufacturing Services LLC received?
Patheon Manufacturing Services LLC 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 Patheon Manufacturing Services LLC come from?
All FDA import refusal data for Patheon Manufacturing Services 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.