FDA Inspection 1068203 — Customed, Inc.

Customed, Inc. — FEI 2648727

The FDA completed an inspection of Customed, Inc. on September 21, 2018 in Fajardo, PR. 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
September 21, 2018
Fiscal Year
2018
Product Type
Devices
Project Area
Radiation Control and Health Safety Act
Location
Fajardo, PR (United States)

Citations

IDCFRDescription
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures
48621 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements