FDA Inspection 1103441 — Astute Choice Packaging

Astute Choice Packaging — FEI 3017538679

The FDA completed an inspection of Astute Choice Packaging on September 30, 2019 in Henrico, VA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 30, 2019
Fiscal Year
2019
Product Type
Devices
Project Area
Compliance: Devices
Location
Henrico, VA (United States)

Citations

IDCFRDescription
319921 CFR 820.40(a)Document review, approval documentation
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures
54621 CFR 820.75(a)Lack of or inadequate process validation