FDA Inspection 1111215 — Consolidated Machine Corp.

Consolidated Machine Corp. — FEI 1219189

The FDA completed an inspection of Consolidated Machine Corp. on Nov 27, 2019 in Billerica, MA. 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
Nov 27, 2019
Fiscal Year
2020
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Billerica, MA (United States)

Citations

IDCFRDescription
260421 CFR 820.30(e)Design review - Lack of or inadequate procedures
405921 CFR 820.22Quality Audits - defined intervals