FDA Inspection 698016 — AG Industries LLC

AG Industries LLC — FEI 3004874794

The FDA completed an inspection of AG Industries LLC on Nov 11, 2010 in Fairburn, GA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Nov 11, 2010
Fiscal Year
2011
Product Type
Devices
Project Area
Compliance: Devices
Location
Fairburn, GA (United States)

Citations

IDCFRDescription
310421 CFR 820.30(j)Design history file
312121 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
312521 CFR 820.80(d)Lack of or inadequate final acceptance procedures
333121 CFR 820.181DMR - not or inadequately maintained

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.