FDA Inspection 1218179 — Johnson & Johnson Medical (Suzhou) Ltd.

Johnson & Johnson Medical (Suzhou) Ltd. — FEI 3006356043

The FDA completed an inspection of Johnson & Johnson Medical (Suzhou) Ltd. on August 24, 2023 in Suzhou. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 24, 2023
Fiscal Year
2023
Product Type
Devices
Project Area
Bioresearch Monitoring
Location
Suzhou (China)

Additional Details

Postmarket Audit Inspections

Citations

IDCFRDescription
54121 CFR 820.70(c)Environmental control Lack of or inadequate procedures