FDA Inspection 1058782 — DuoProSS Meditech Corporation

DuoProSS Meditech Corporation — FEI 3003681915

The FDA completed an inspection of DuoProSS Meditech Corporation on Jul 13, 2018 in Farmingdale, NY. 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
Jul 13, 2018
Fiscal Year
2018
Product Type
Devices
Project Area
Compliance: Devices
Location
Farmingdale, NY (United States)

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures
316821 CFR 820.198(a)Complaints
63021 CFR 803.17Lack of Written MDR Procedures

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