1021977

J&T Health and Wellness LLC — FEI 1000525872

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
August 4, 2017
Fiscal Year
2017
Product Type
Devices
Project Area
Compliance: Devices
Location
Saint Petersburg, FL (United States)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
1472221 CFR 820.40Procedures not adequately established or maintained
232721 CFR 820.22Quality audits - Lack of or inadequate procedures
312521 CFR 820.80(d)Lack of or inadequate final acceptance procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
323321 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
333121 CFR 820.181DMR - not or inadequately maintained
54121 CFR 820.70(c)Environmental control Lack of or inadequate procedures
63021 CFR 803.17Lack of Written MDR Procedures