Drug factory · FDA FEI 1410248
CSL Behring L.L.C.
1201 N Kinzie Ave, Bradley, IL, United States
Problems found, fixed voluntarily at FDA's last inspection, Jul 28, 2014.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
4 drug inspections on record since 2009: 2 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| .alpha.1-Proteinase Inhibitor Human | Makes it | CSL Behring | 0053-7201, 0053-7202, 0053-7203 |
| Albutrepenonacog Alfa | Makes it | CSL Behring Lengnau AG | 69911-864, 69911-865, 69911-866 +2 |
| Etranacogene Dezaparvovec | Makes it | CSL Behring | 0053-0100, 0053-0110, 0053-0120 +36 |
| Lonoctocog Alfa | Makes it | CSL Behring Lengnau AG | 69911-474, 69911-475, 69911-476 +4 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 28, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| May 30, 2013 | No problems found | Drug Quality Assurance | — |
| Sep 10, 2012 | No problems found | Drug Quality Assurance | — |
| Jun 5, 2009 | Problems found, fixed voluntarily | 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.
Jul 28, 2014 inspection
- Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity. - 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.
Registered with FDA for: manufacture.