FDA Inspection 1167016 — Exogenesis Corporation

Exogenesis Corporation — FEI 3009492128

The FDA completed an inspection of Exogenesis Corporation on Apr 12, 2022 in Billerica, 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
Apr 12, 2022
Fiscal Year
2022
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Billerica, MA (United States)

Citations

IDCFRDescription
326321 CFR 820.250(b)Sampling plans
54121 CFR 820.70(c)Environmental control Lack of or inadequate procedures