Drug factory · FDA FEI 2129896
PPD Development, L.P.
8551 Research Way, Suite 90, Middleton, WI, United States
Problems found, fixed voluntarily at FDA's last inspection, Sep 25, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
6 drug inspections on record since 2009: 4 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Buprenorphine and Naloxone | Tests it | Indivior Inc. | 12496-1202, 12496-1204, 12496-1208 +1 |
| Elranatamab | Tests it | Pfizer Laboratories Div Pfizer Inc | 0069-2522, 0069-4494 |
| Epinephrine | Tests it | Amneal Pharmaceuticals | 0115-1694, 0115-1695 |
| Esketamine | Tests it | Janssen Pharmaceuticals, Inc. | 50458-028 |
| Manganese Cation (2+) | Tests it | Hospira, Inc. | 0409-4091 |
| Methotrexate | Tests it | Antares Pharma, Inc. | 54436-010, 54436-012, 54436-015 +4 |
| Metoclopramide | Tests it | Hospira, Inc. | 0409-3414 |
| Motixafortide | Tests it | BioLineRx USA Inc, Gamida Cell Inc. | 82737-073, 73441-062 |
| Oritavancin | Tests it | Melinta Therapeutics, LLC | 70842-140, 70842-225 |
| Susoctocog Alfa | Tests it | Takeda Pharmaceuticals America, Inc. | 0944-5001 |
| Tapinarof | Tests it | Organon LLC | 81672-5051 |
| Tovorafenib | Tests it | Day One Biopharmaceuticals, Inc. | 82950-001, 82950-012 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 25, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Sep 19, 2019 | No problems found | Drug Quality Assurance | — |
| May 18, 2018 | Problems found, fixed voluntarily | Bioresearch Monitoring | — |
| Nov 20, 2013 | No problems found | Drug Quality Assurance | — |
| Nov 9, 2011 | No problems found | Drug Quality Assurance | — |
| Jul 24, 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.
Sep 25, 2025 inspection
- Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing. - Training , Education , Experience overall 21 CFR 211.25(a)
Employees engaged in the processing of a drug product lack the training required to perform their assigned functions. - Equipment for Environmental Control 21 CFR 211.46(b)
Equipment for adequate control over humidity and temperature is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.
Registered with FDA for: analysis.