Drug factory · FDA FEI 3003708554
Fresenius Kabi Austria
Hafnerstrasse 36 or am Gewerbepark 6, Graz, Werndorf, Austria 8055, Austria
Problems found, fixed voluntarily at FDA's last inspection, Mar 21, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
9 drug inspections on record since 2009: 2 with no problems, 7 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 21, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 13, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 30, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 8, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 17, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | 6 |
| Jun 19, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Jul 16, 2013 | No problems found | Drug Quality Assurance | — |
| Mar 25, 2011 | No problems found | Drug Quality Assurance | — |
| Jul 3, 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.
Mar 17, 2017 inspection
- Computerized records 21 CFR 123.9(f)
Your computerized records do not provide that appropriate controls are implemented to ensure the integrity of the electronic data and signatures. - Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed. - No written record of investigation 21 CFR 211.192
Written records are not always made of investigations into unexplained discrepancies. - Environmental Monitoring System 21 CFR 211.42(c)(10)(iv)
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. - Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Jun 19, 2015 inspection
- Written record of investigation incomplete 21 CFR 211.192
Written records of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications do not include the conclusions and follow-up. - Sample identification and other information 21 CFR 211.194(a)(1)
Laboratory records do not include the source or location from where the sample was obtained.
Registered with FDA for: analysis; manufacture; pack; repack.