FDA Inspection 1171225 — DiaPharma Group Inc

DiaPharma Group Inc — FEI 3000719074

The FDA completed an inspection of DiaPharma Group Inc on April 29, 2022 in West Chester, OH. 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
April 29, 2022
Fiscal Year
2022
Product Type
Devices
Project Area
Compliance: Devices
Location
West Chester, OH (United States)

Citations

IDCFRDescription
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures