FDA Inspection 1170583 — Myllan-ORA Ehf

Myllan-ORA Ehf — FEI 3001017171

The FDA completed an inspection of Myllan-ORA Ehf on May 25, 2022 in Kopavogur. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 4 citations were issued during this inspection. Product area: Food/Cosmetics.

Inspection Details

Classification
Official Action Indicated (OAI)
End Date
May 25, 2022
Fiscal Year
2022
Product Type
Food/Cosmetics
Project Area
Foodborne Biological Hazards
Location
Kopavogur (Iceland)

Citations

IDCFRDescription
152421 CFR 123.11(b)Sanitation monitoring
600421 CFR 123.6(c)(4)Monitoring - adequacy
96021 CFR 123.6(c)(2)Critical control points
96321 CFR 123.6(c)(5)Corrective action plan

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.