FDA Inspection 1089531 — Acme Monaco Corporation

Acme Monaco Corporation — FEI 1293141

The FDA completed an inspection of Acme Monaco Corporation on Apr 17, 2019 in New Britain, CT. 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
Apr 17, 2019
Fiscal Year
2019
Product Type
Devices
Project Area
Compliance: Devices
Location
New Britain, CT (United States)

Citations

IDCFRDescription
315921 CFR 820.184DHR content
322621 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule

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