Company
United StatesPatheon Manufacturing Services LLC, Jr. Hwy. Greenville, NC – FDA Inspections
Inspection records and compliance data for Patheon Manufacturing Services LLC in Jr. Hwy. Greenville, NC. 18 FDA inspections on record, 4 Form 483s, 1 warning letter, last inspected September 26, 2025.
Company Profile
This profile covers Patheon Manufacturing Services LLC based in Jr. Hwy. Greenville, NC, United States.
FDA Inspection History
- FDA inspections
- 18
- OAI
- 0
- VAI
- 7
- NAI
- 8
- Unclassified
- 3
- Form 483s
- 4
- Warning letters
- 1
First inspected September 2, 2009. Last inspected September 26, 2025.
Most cited issue areas
- Following/documenting laboratory controls2 inspections
- Procedures for sterile drug products2 inspections
- Absence of Written Procedures1 inspection
FDA inspections (18)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 26, 2025 | NAI | Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance | 1270187 |
| November 27, 2024 | Not classified | Biologics | 1257333 |
| May 24, 2024 | Not classified | Human Drugs · Drug Quality Assurance | 1238532 |
| February 23, 2024 | VAI | Biologics · Vaccines and Allergenic Products | 1229060 |
| August 4, 2022 | VAI | Biologics · Vaccines and Allergenic Products | 1176425 |
| May 17, 2019 | NAI | Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance | 1096860 |
| July 17, 2018 | VAI | Biologics · Vaccines and Allergenic Products | 1060475 |
| March 28, 2018 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1055334 |
| April 20, 2017 | NAI | Human Drugs · Drug Quality Assurance | 1019511 |
| November 18, 2016 | Not classified | Biologics | 996761 |
| December 17, 2015 | VAI | Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance | 985597 |
| September 12, 2014 | VAI | Human Drugs · Drug Quality Assurance | 896809 |
| April 11, 2014 | VAI | Human Drugs · Drug Quality Assurance | 876160 |
| January 25, 2013 | NAI | Human Drugs · Drug Quality Assurance | 840598 |
| April 20, 2012 | VAI | Human Drugs · Drug Quality Assurance | 778578 |
| April 21, 2011 | NAI | Human Drugs · Drug Quality Assurance | 744550 |
| June 18, 2010 | NAI | Animal Drugs & Feeds, Human Drugs · Monitoring of Marketed Animal Drugs, Feed, and Devices | 669033 |
| September 2, 2009 | NAI | Human Drugs · Drug Quality Assurance | 613370 |
FDA documents
Form 483s (10)
Warning Letters (1)
People (5)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Patheon Manufacturing Services LLC
FEI Number
1018495
Address
5900 Martin Luther King, Jr. Hwy. Greenville, NC 2783, United States
Country
United States
ID: 64087a9c-0f9c-44d7-aeb9-171f7bc13658