FDA Inspection 838601 — Alfa Scientific Designs Inc

Alfa Scientific Designs Inc — FEI 3001452245

The FDA completed an inspection of Alfa Scientific Designs Inc on June 20, 2013 in Poway, CA. 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: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 20, 2013
Fiscal Year
2013
Product Type
Devices
Project Area
Compliance: Devices
Location
Poway, CA (United States)

Citations

IDCFRDescription
1471021 CFR 820.150Lack of or inadequate procedures for storage.
311921 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
323321 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ