FDA Inspection 647781 — General Physiotherapy II LLC

General Physiotherapy II LLC — FEI 1000147357

The FDA completed an inspection of General Physiotherapy II LLC on February 22, 2010 in Saint Charles, MO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 22, 2010
Fiscal Year
2010
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Saint Charles, MO (United States)

Citations

IDCFRDescription
337021 CFR 820.198(a)(2)Oral complaints
337121 CFR 820.198(a)(3)Processing MDRs {see also 803, 804}
63021 CFR 803.17Lack of Written MDR Procedures