FDA Inspection 1199112 — Barrett Technology, LLC

Barrett Technology, LLC — FEI 3012251430

The FDA completed an inspection of Barrett Technology, LLC on March 7, 2023 in Newton, MA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 5 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
March 7, 2023
Fiscal Year
2023
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Newton, MA (United States)

Citations

IDCFRDescription
1471021 CFR 820.150Lack of or inadequate procedures for storage.
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
232721 CFR 820.22Quality audits - Lack of or inadequate procedures
235021 CFR 820.25(b)Training - Lack of or inadequate procedures
313021 CFR 820.100(a)Lack of or inadequate procedures