FDA Inspection 773089 — Tepha Incorporated

Tepha Incorporated — FEI 3005670760

The FDA completed an inspection of Tepha Incorporated on Feb 16, 2012 in Lexington, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 1 citation was issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Feb 16, 2012
Fiscal Year
2012
Product Type
Devices
Project Area
Compliance: Devices
Location
Lexington, MA (United States)

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures