1092666

RNV LLC — FEI 3026274805

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
June 17, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Miami Lakes, FL (United States)

Citations

IDCFRDescription
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
1552121 CFR 111.27(d)(6)Cleaning compounds - adequate, safe
1573221 CFR 111.365(a)Conditions, controls -protect; microorganisms, contamination
1585821 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
1586921 CFR 111.75(c)Specifications met - verify; finished batch
1815121 CFR 117.40(f)Instruments and Controls
1906621 CFR 117.165(b)Sanitation Controls Verif Procedures: Establish Implement
202721 CFR 211.192Investigations of discrepancies, failures
357121 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
358521 CFR 211.110(a)Control procedures to monitor and validate performance
361121 CFR 211.160(b)(3)Acceptance of drug products