FDA Inspection 598567 — D.B.I. America Corp.

D.B.I. America Corp. — FEI 1000113513

The FDA completed an inspection of D.B.I. America Corp. on Jul 23, 2009 in Lutz, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI)
End Date
Jul 23, 2009
Fiscal Year
2009
Product Type
Devices
Project Area
Compliance: Devices
Location
Lutz, FL (United States)

Citations

IDCFRDescription
312121 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
317121 CFR 820.198(b)Rationale documented for no investigation