Patheon Manfacturing Services LLC
⚠️ High Risk
FEI: 2246315 • Ridgefield, NJ • UNITED STATES
FEI Number
2246315
Location
Ridgefield, NJ
Country
UNITED STATESAddress
1125 Pleasantview Ter, , Ridgefield, NJ, United States
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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).
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
DE/RX KIT
The article appears to be a combination medical device/prescription drug kit for which the prescription drug component was manufactured in the U.S., is 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.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/17/2023 | 87MOZACID, HYALURONIC, INTRAARTICULAR | 237NO PMA | Division of Northeast Imports (DNEI) |
| 4/26/2023 | 87MOZACID, HYALURONIC, INTRAARTICULAR | 237NO PMA | Division of Northeast Imports (DNEI) |
| 6/20/2018 | 87MOZACID, HYALURONIC, INTRAARTICULAR | 237NO PMA | Division of Northeast Imports (DNEI) |
| 10/26/2017 | 87MOZACID, HYALURONIC, INTRAARTICULAR | 237NO PMA | Division of Southeast Imports (DSEI) |
| 6/19/2012 | 89MOZACID, HYALURONIC, INTRAARTICULAR | 2480RXPERSONAL | New Orleans District Office (NOL-DO) |
| 6/19/2012 | 66SCA51TADALAFIL | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/24/2011 | 89MOZACID, HYALURONIC, INTRAARTICULAR | 341REGISTERED | Philadelphia District Office (PHI-DO) |
| 2/8/2011 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 3340DE/RX KIT | Los Angeles District Office (LOS-DO) |
| 7/27/2006 | 66ADX01HYALURONIDASE (FOR INJECTIONS) (SPREADING AGENT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/13/2006 | 89MOZACID, HYALURONIC, INTRAARTICULAR | 237NO PMA | Cincinnati District Office (CIN-DO) |
| 3/30/2006 | 89MOZACID, HYALURONIC, INTRAARTICULAR | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/30/2006 | 66VDP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/13/2003 | 76MGGFLUID, HYLAN (FOR TMJ USE) | 223FALSE | Seattle District Office (SEA-DO) |
| 8/25/2003 | 87LMLLIGAMENTS AND TENDONS, SYNTHETIC | San Francisco District Office (SAN-DO) | |
| 5/1/2003 | 80KZHINTRODUCER, SYRINGE NEEDLE | 118NOT LISTED | Detroit District Office (DET-DO) |
| 4/30/2003 | 76EJISYRINGE, CARTRIDGE | 118NOT LISTED | Detroit District Office (DET-DO) |
| 4/30/2003 | 76EJISYRINGE, CARTRIDGE | 118NOT LISTED | Detroit District Office (DET-DO) |
| 4/30/2003 | 76EJISYRINGE, CARTRIDGE | 118NOT LISTED | Detroit District Office (DET-DO) |
| 4/30/2003 | 76EJISYRINGE, CARTRIDGE | 118NOT LISTED | Detroit District Office (DET-DO) |
| 4/30/2003 | 76EJISYRINGE, CARTRIDGE | 118NOT LISTED | Detroit District Office (DET-DO) |
| 4/30/2003 | 79FGYCANNULA, INJECTION | 118NOT LISTED | Detroit District Office (DET-DO) |
| 4/28/2003 | 76EJISYRINGE, CARTRIDGE | 118NOT LISTED | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Patheon Manfacturing Services LLC's FDA import refusal history?
Patheon Manfacturing Services LLC (FEI: 2246315) has 22 FDA import refusal record(s) in our database, spanning from 4/28/2003 to 5/17/2023.
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 Manfacturing Services LLC's FEI number is 2246315.
What types of violations has Patheon Manfacturing Services LLC received?
Patheon Manfacturing Services LLC has been cited for 8 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 Manfacturing Services LLC come from?
All FDA import refusal data for Patheon Manfacturing 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.