1249317

Parnell Manufacturing Pty, Ltd. — FEI 3003245034

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 17, 2024
Fiscal Year
2024
Product Type
Veterinary
Project Area
Monitoring of Marketed Animal Drugs, Feed, and Devices
Location
Alexandria (Australia)

Citations

IDCFRDescription
122021 CFR 211.67(b)(3)Cleaning SOPs/instructions
143521 CFR 211.42(c)(10)(v)Cleaning System
145221 CFR 211.113(b)Validation lacking for sterile drug products
202721 CFR 211.192Investigations of discrepancies, failures