FDA Inspection 829602 — Adventist HealthCare Shady Grove Medical Center

Adventist HealthCare Shady Grove Medical Center — FEI 1177751

The FDA completed an inspection of Adventist HealthCare Shady Grove Medical Center on April 29, 2013 in Rockville, MD. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Biologics.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 29, 2013
Fiscal Year
2013
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Rockville, MD (United States)

Citations

IDCFRDescription
9421 CFR 606.100(b)(15)Schedules and procedures for equipment & calibration