1275229

Little Moon Essentials LLC — FEI 3017366969

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
July 10, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Dania Beach, FL (United States)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
126121 CFR 211.68(a)Written calibration / inspection records not kept
136121 CFR 211.100(a)Absence of Written Procedures
154021 CFR 211.125(a)Strict control not exercised over labeling issued
191421 CFR 211.166(a)Lack of written stability program
194221 CFR 211.180(e)Records reviewed annually
201221 CFR 211.188(b)Batch production and Batch Control Record Requirements
431421 CFR 211.84(d)(2)Reports of Analysis (Components)