1272520

CDL Services, Inc. — FEI 3012112742

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
April 28, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Anaheim, CA (United States)

Citations

IDCFRDescription
117721 CFR 211.63Equipment Design, Size and Location
121521 CFR 211.67(b)Written procedures not established/followed
136121 CFR 211.100(a)Absence of Written Procedures
188321 CFR 211.165(a)Testing and release for distribution
191421 CFR 211.166(a)Lack of written stability program
200921 CFR 211.188Prepared for each batch, include complete information
431421 CFR 211.84(d)(2)Reports of Analysis (Components)
900121 CFR 211.22(a)Lack of quality control unit