1158151

Wedgewood Connect, LLC — FEI 3003434972

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 3, 2021
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
San Jose, CA (United States)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
145121 CFR 211.113(b)Procedures for sterile drug products
202721 CFR 211.192Investigations of discrepancies, failures