FRESENIUS KABI AUSTRIA GMBH
Overview
FRESENIUS KABI AUSTRIA GMBH is an active pharmaceutical ingredient (API) supplier with 3 active FDA Type II Drug Master Files, covering LACTULOSE CONCENTRATE USP; LACTULOSE CRYSTALS; LACTULOSE SOLUTION USP.
Core services & business areas
API / Drug Master Files
FRESENIUS KABI AUSTRIA GMBH holds 3 active (4 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.
- LACTULOSE CONCENTRATE USPActive2007-05-29
- LACTULOSE SOLUTION USPActive2001-02-16
- LACTULOSE CRYSTALSActive2001-02-16
- LACTULOSE SOLUTION USPInactive2008-12-20
FDA compliance signals
7 FDA enforcement records linked to this company.
- 4832017-03-17
No written record of investigation
- 4832017-03-17
Scientifically sound laboratory controls
- 4832017-03-17
Environmental Monitoring System
- 4832017-03-17
Investigations of discrepancies, failures
- 4832017-03-17
Cleaning / Sanitizing / Maintenance
- 4832015-06-19
Sample identification and other information
- 4832015-06-19
Written record of investigation incomplete
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