974115

Rhythmedix LLC — FEI 3011265784

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 27, 2016
Fiscal Year
2016
Product Type
Devices
Project Area
Compliance: Devices
Location
Mount Laurel, NJ (United States)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
1472221 CFR 820.40Procedures not adequately established or maintained
232821 CFR 820.22Quality audits - auditor independence
313021 CFR 820.100(a)Lack of or inadequate procedures
315921 CFR 820.184DHR content
323321 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
333121 CFR 820.181DMR - not or inadequately maintained