FDA Inspection 654358 — Myerson LLC

Myerson LLC — FEI 3003928050

The FDA completed an inspection of Myerson LLC on March 19, 2010 in Chicago, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 19, 2010
Fiscal Year
2010
Product Type
Devices
Project Area
Compliance: Devices
Location
Chicago, IL (United States)

Citations

IDCFRDescription
227921 CFR 820.20(b)(2)Resources
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
369621 CFR 820.100(b)Documentation
418921 CFR 820.198(a)General
44721 CFR 820.40Lack of procedures, or not maintained