FDA Inspection 1242880 — Wild Child Laboratories Pty Ltd.

Wild Child Laboratories Pty Ltd. — FEI 3006210769

The FDA completed an inspection of Wild Child Laboratories Pty Ltd. on June 21, 2024 in Osborne Park. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
June 21, 2024
Fiscal Year
2024
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Osborne Park (Australia)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
122021 CFR 211.67(b)(3)Cleaning SOPs/instructions
136121 CFR 211.100(a)Absence of Written Procedures
145021 CFR 211.113(a)Procedures for non-sterile drug products
188321 CFR 211.165(a)Testing and release for distribution
192021 CFR 211.166(a)(3)Valid stability test methods
202721 CFR 211.192Investigations of discrepancies, failures