Source: FDA inspection record. Confirmed against FDA's published inspection data for this establishment and inspection date. FDA has published the inspection and what it cited, but not the form itself, which usually takes six to twelve months. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3002495042.
Observations4
Issue DateJanuary 24, 2025
Status1 Related Warning Letter
Related Inspections3
Establishment Details
Firm
SEDECAL SA
Location
Algete, Spain
FEI Number
3002495042
Product Type
Devices
Issue Date
January 24, 2025
Country
Spain
Inspection History, 2010 to 2025
NAI1
VAI1
OAI1
NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.
Talk to a Specialist