1179911

BAXALTA US INC. — FEI 3012385969

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
September 15, 2022
Fiscal Year
2022
Product Type
Biologics
Project Area
Vaccines and Allergenic Products
Location
Round Lake, IL (United States)

Citations

IDCFRDescription
184621 CFR 211.84(d)(3)Establish reliability of supplier's C of A
202721 CFR 211.192Investigations of discrepancies, failures
432021 CFR 211.84(d)(6)Microbiological Contamination Exam