FDA Inspection 736778 — Organogenesis, Inc.

Organogenesis, Inc. — FEI 1000148471

The FDA completed an inspection of Organogenesis, Inc. on Jul 29, 2011 in Canton, MA. 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 29, 2011
Fiscal Year
2011
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Canton, MA (United States)

Citations

IDCFRDescription
1472221 CFR 820.40Procedures not adequately established or maintained
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures