FDA Inspection 675470 — Tucker Designs Ltd

Tucker Designs Ltd — FEI 1000112533

The FDA completed an inspection of Tucker Designs Ltd on Aug 11, 2010 in Metairie, LA. 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). 2 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Aug 11, 2010
Fiscal Year
2010
Product Type
Devices
Project Area
Compliance: Devices
Location
Metairie, LA (United States)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
63021 CFR 803.17Lack of Written MDR Procedures