FDA Inspection 1020211 — Synergy Health AST LLC

Synergy Health AST LLC — FEI 1000515342

The FDA completed an inspection of Synergy Health AST LLC on Aug 2, 2017 in Lima, 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). 2 citations were issued during this inspection. Product area: Devices.

Inspection details

Classification
Voluntary Action Indicated (VAI)
End Date
Aug 2, 2017
Fiscal Year
2017
Product Type
Devices
Project Area
Compliance: Devices
Location
Lima, OH (United States)

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures

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