638618

Alcor Scientific, Inc. — FEI 3003855297

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
December 31, 2009
Fiscal Year
2010
Product Type
Devices
Project Area
Compliance: Devices
Location
Smithfield, RI (United States)

Citations

IDCFRDescription
233021 CFR 820.22Quality audit corrective action, reaudits {see also 820.100}
235121 CFR 820.25(b)Training
312821 CFR 820.90(a)Nonconforming product control
313221 CFR 820.120Lack of or inadequate procedures for labeling
313921 CFR 820.140Lack of or inadequate procedures for handling
315921 CFR 820.184DHR content
317021 CFR 820.198(b)Review and evaluation for investigation
326221 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
336921 CFR 820.198(a)(1)Uniform and timely processing
337021 CFR 820.198(a)(2)Oral complaints
342821 CFR 820.50(a)(3)Acceptable supplier records
369621 CFR 820.100(b)Documentation
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures
53721 CFR 820.70(a)Production processes