1255959

Dynamic Blending Specialists, Inc. — FEI 3013719300

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
December 6, 2024
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Vineyard, UT (United States)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
121521 CFR 211.67(b)Written procedures not established/followed
180121 CFR 211.84(a)Components withheld from use pending release
191421 CFR 211.166(a)Lack of written stability program
360321 CFR 211.160(b)Scientifically sound laboratory controls
431421 CFR 211.84(d)(2)Reports of Analysis (Components)