FDA Inspection 1048098 — C2C Development, LLC

C2C Development, LLC — FEI 3011193444

The FDA completed an inspection of C2C Development, LLC on April 10, 2018 in Melbourne, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 10, 2018
Fiscal Year
2018
Product Type
Devices
Project Area
Compliance: Devices
Location
Melbourne, FL (United States)

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures
54621 CFR 820.75(a)Lack of or inadequate process validation