FDA Inspection 759307 — Respiratory Technologies, Inc.

Respiratory Technologies, Inc. — FEI 3004961434

The FDA completed an inspection of Respiratory Technologies, Inc. on Nov 17, 2011 in Plymouth, MN. 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
Nov 17, 2011
Fiscal Year
2012
Product Type
Devices
Project Area
Compliance: Devices
Location
Plymouth, MN (United States)

Citations

IDCFRDescription
237121 CFR 820.30(a)Design control - no procedures
313021 CFR 820.100(a)Lack of or inadequate procedures