FDA Inspection 786617 — Munson Medical Center

Munson Medical Center — FEI 1873407

The FDA completed an inspection of Munson Medical Center on June 14, 2012 in Traverse City, MI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 14, 2012
Fiscal Year
2012
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Traverse City, MI (United States)

Citations

IDCFRDescription
15521 CFR 606.160(b)Required records
15921 CFR 606.160(a)(1)Legibility and indelibility
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs