FDA Inspection 895260 — Maguire Enterprises, Inc.

Maguire Enterprises, Inc. — FEI 1049754

The FDA completed an inspection of Maguire Enterprises, Inc. on September 10, 2014 in Sunrise, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 10, 2014
Fiscal Year
2014
Product Type
Devices
Project Area
Compliance: Devices
Location
Sunrise, FL (United States)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures