1282386

PEARMINE HEALTH LTD — FEI 3014428888

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 19, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Brackley (United Kingdom)

Citations

IDCFRDescription
121521 CFR 211.67(b)Written procedures not established/followed
184421 CFR 211.84(d)(2)Establish reliability of supplier's C of A
188321 CFR 211.165(a)Testing and release for distribution
191421 CFR 211.166(a)Lack of written stability program
358521 CFR 211.110(a)Control procedures to monitor and validate performance