1279930

Bio-Medical Pharmaceutical Manufacturing Corporation — FEI 1650090

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
August 29, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Houston, TX (United States)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
117721 CFR 211.63Equipment Design, Size and Location
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
145121 CFR 211.113(b)Procedures for sterile drug products
182321 CFR 211.84(c)(4)Top/Middle/Bottom container sampling
188321 CFR 211.165(a)Testing and release for distribution
201321 CFR 211.188(b)(1)Significant Step Accomplishment Dates
434221 CFR 211.142(b)Storage under appropriate conditions