FDA Inspection 1006140 — Pos-T-Vac, LLC.

Pos-T-Vac, LLC. — FEI 1931563

The FDA completed an inspection of Pos-T-Vac, LLC. on Mar 14, 2017 in Dodge City, KS. 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
Mar 14, 2017
Fiscal Year
2017
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Dodge City, KS (United States)

Citations

IDCFRDescription
316821 CFR 820.198(a)Complaints
369621 CFR 820.100(b)Documentation
63021 CFR 803.17Lack of Written MDR Procedures