FDA Inspection 752242 — Affymetrix, Inc.

Affymetrix, Inc. — FEI 3003314809

The FDA completed an inspection of Affymetrix, Inc. on October 14, 2011 in Santa Clara, CA. 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: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 14, 2011
Fiscal Year
2012
Product Type
Devices
Project Area
Compliance: Devices
Location
Santa Clara, CA (United States)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures