1087147

QuVa Pharma, Inc. — FEI 3012053582

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
April 23, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Sugar Land, TX (United States)

Citations

IDCFRDescription
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
145121 CFR 211.113(b)Procedures for sterile drug products
202621 CFR 211.192Quality control unit review of records
202821 CFR 211.192Extent of discrepancy, failure investigations
354721 CFR 211.46(b)Equipment for Environmental Control