953823

Temmler Pharma GmbH & Co. KG — FEI 3002808339

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 4, 2015
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Marburg (Germany)

Citations

IDCFRDescription
180121 CFR 211.84(a)Components withheld from use pending release
188521 CFR 211.165(b)Microbiological testing
436421 CFR 211.176Failing to test for penicillin cross-contamination