Drug factory · FDA FEI 3004110157
Patheon Italia S.p.A
2° Trav. SX Via Morolense, 5, Ferentino, Italy
Problems found, fixed voluntarily at FDA's last inspection, Feb 25, 2022.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
7 drug inspections on record since 2009: 1 with no problems, 5 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Aflibercept | Makes it and tests it | CELLTRION USA, Inc. | 72606-026 |
| Dantrolene | Makes it, tests it, packages it and labels it | Uswm, LLC | 78670-003 |
| Defibrotide Free Acid | Makes it | Jazz Pharmaceuticals, Inc. | 68727-800 |
| Diatrizoic Acid | Makes it and tests it | Bracco Diagnostics Inc. | 0270-0149, 0270-1410 |
| Efgartigimod Alfa | Makes it | argenx US | 73475-3041 |
| Efgartigimod Alfa and Hyaluronidase (human Recombinant) | Makes it | argenx US | 73475-3102 |
| Efmoroctocog Alfa | Makes it and tests it | Bioverativ Therapeutics Inc. | 71104-801, 71104-802, 71104-803 +7 |
| Gadolinium Cation (3+) | Makes it and tests it | Bracco Diagnostics Inc. | 0270-5164, 0270-5264 |
| Iomeprol | Makes it and tests it | Bracco Diagnostics Inc. | 0270-7250, 0270-7300, 0270-7350 +4 |
| Iopamidol | Makes it and tests it | Bracco Diagnostics Inc. | 0270-1314, 0270-1315, 0270-1316 +3 |
| Rifampin | Makes it, tests it and packages it | Akorn | 17478-151 |
| Thrombin Alfa | Makes it and tests it | The Medicines Company | 65293-006, 65293-007 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 25, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 21, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 16, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 19, 2015 | Serious problems, FDA action | Drug Quality Assurance | — |
| Jun 21, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | 6 |
| Nov 11, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 22, 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.
Jun 21, 2013 inspection
- Control procedures to monitor and validate performance 21 CFR 211.110(a)
Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. - Labels and labeling stored separately 21 CFR 211.122(d)
Labels and other labeling materials are not stored separately with suitable identification for each different drug product, strength, dosage form or quantity of contents. - Complaint Handling Procedure 21 CFR 211.198(a)
Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed. - 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 and fully followed. - Cleaning/maintenance records not kept 21 CFR 211.67(c)
Records are not kept for the inspection of equipment. - Reports of Analysis (Components) 21 CFR 211.84(d)(2)
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.
Registered with FDA for: analysis; label; manufacture; pack; sterilize.