1077545

PLD Acquisitions LLC — FEI 2000009210

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 30, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Doral, FL (United States)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
119421 CFR 211.42(c)Defined areas of adequate size for operations
121521 CFR 211.67(b)Written procedures not established/followed
121921 CFR 211.67(b)(2)Cleaning SOPs/schedules
202721 CFR 211.192Investigations of discrepancies, failures