FDA Inspection 1177676 — Mendell Machine And Manufacturing LLC

Mendell Machine And Manufacturing LLC — FEI 3009998573

The FDA completed an inspection of Mendell Machine And Manufacturing LLC on Aug 3, 2022 in Lakeville, MN. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI)
End Date
Aug 3, 2022
Fiscal Year
2022
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Lakeville, MN (United States)

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures
320321 CFR 820.40(b)Document change records, maintained.

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