FDA Inspection 879923 — Flawless Beauty and Skin

Flawless Beauty and Skin — FEI 3011055149

The FDA completed an inspection of Flawless Beauty and Skin on May 16, 2014 in Ocean, NJ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Food/Cosmetics.

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
May 16, 2014
Fiscal Year
2014
Product Type
Food/Cosmetics
Project Area
Foodborne Biological Hazards
Location
Ocean, NJ (United States)

Citations

IDCFRDescription
136121 CFR 211.100(a)Absence of Written Procedures
1471121 CFR 820.160(a)Lack of or inadequate procedures for distribution
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
1579721 CFR 111.553Written procedures - product complaint
1586921 CFR 111.75(c)Specifications met - verify; finished batch
177721 CFR 211.150(b)Distribution Recall System
191421 CFR 211.166(a)Lack of written stability program
200921 CFR 211.188Prepared for each batch, include complete information
241921 CFR 211.198(a)Complaint Handling Procedure
900121 CFR 211.22(a)Lack of quality control unit