Drug factory · FDA FEI 1018495
Patheon Manufacturing Services LLC
5900 Martin Luther King Jr. Highway, Greenville, NC, United States
No problems found at FDA's last inspection, Sep 26, 2025.
No Action Indicated: inspectors found no objectionable conditions.
11 drug inspections on record since 2009: 7 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 26, 2025 | No problems found | Drug Quality Assurance | — |
| May 17, 2019 | No problems found | Drug Quality Assurance | — |
| Apr 20, 2017 | No problems found | Drug Quality Assurance | — |
| Dec 17, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Sep 12, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 11, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 25, 2013 | No problems found | Drug Quality Assurance | — |
| Apr 20, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 21, 2011 | No problems found | Drug Quality Assurance | — |
| Jun 18, 2010 | No problems found | Drug Quality Assurance | — |
| Sep 2, 2009 | No problems found | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Dec 17, 2015 inspection
- Actual vs. theoretical yields not determined 21 CFR 211.103
Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate phase of packaging of the drug product. - Storage under appropriate conditions 21 CFR 211.142(b)
Drug products are not stored under appropriate conditions of temperature and humidity so that their identity, strength, quality, and purity are not affected. - Following/documenting laboratory controls 21 CFR 211.160(a)
Established laboratory control mechanisms are not followed and documented at the time of performance .
Registered with FDA for: analysis; label; manufacture; pack.