FDA Inspection 1238761 — Surgical Technology Laboratories, Inc

Surgical Technology Laboratories, Inc — FEI 1825527

The FDA completed an inspection of Surgical Technology Laboratories, Inc on May 10, 2024 in Lugoff, SC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 10, 2024
Fiscal Year
2024
Product Type
Devices
Project Area
Compliance: Devices
Location
Lugoff, SC (United States)

Citations

IDCFRDescription
2142421 CFR 820.120(b)Labeling inspection - UDI
331321 CFR 820.120(d)Records, DHR {see also 820.184(e)}