FDA Inspection 1280844 — Design And Services Hub

Design And Services Hub — FEI 3016575387

The FDA completed an inspection of Design And Services Hub on Sep 8, 2025 in Hartville, OH. 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
Sep 8, 2025
Fiscal Year
2025
Product Type
Devices
Project Area
Compliance: Devices
Location
Hartville, OH (United States)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
328621 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures

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