FDA Inspection 916761 — Gelflex Laboratories

Gelflex Laboratories — FEI 1000426389

The FDA completed an inspection of Gelflex Laboratories on Jan 30, 2015 in Malaga. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 1 citation was issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI)
End Date
Jan 30, 2015
Fiscal Year
2015
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Malaga (Australia)

Citations

IDCFRDescription
323321 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ