FDA Inspection 641105 — Midwest Women's Healthcare Specialists

Midwest Women's Healthcare Specialists — FEI 3006404428

The FDA completed an inspection of Midwest Women's Healthcare Specialists on January 27, 2010 in Kansas City, MO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 27, 2010
Fiscal Year
2010
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Kansas City, MO (United States)

Citations

IDCFRDescription
1221321 CFR 1271.47(a)Testing, screening, donor eligibility procedures
1230121 CFR 1271.150(c)(1)(iii)Ensurane of compliance