FDA Inspection 810442 — Limerick Inc

Limerick Inc — FEI 3002297831

The FDA completed an inspection of Limerick Inc on Dec 7, 2012 in Burbank, CA. 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). 3 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Dec 7, 2012
Fiscal Year
2013
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Burbank, CA (United States)

Citations

IDCFRDescription
323321 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
333121 CFR 820.181DMR - not or inadequately maintained
63021 CFR 803.17Lack of Written MDR Procedures

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