FDA Inspection 1250841 — Space Maintainers Lab

Space Maintainers Lab — FEI 2082148

The FDA completed an inspection of Space Maintainers Lab on October 3, 2024 in Chatsworth, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
October 3, 2024
Fiscal Year
2025
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Chatsworth, CA (United States)

Citations

IDCFRDescription
235021 CFR 820.25(b)Training - Lack of or inadequate procedures
316021 CFR 820.184Lack of or inadequate DHR procedures