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FCM SMART CENTER GROUP — FDA Facility Profile

FEI 3009545593

FCM SMART CENTER GROUP is an FDA-registered facility (FEI 3009545593) located in Odessa, FL, US. RegDataLab tracks 1 FDA inspection at this facility.

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What FDA found at this site

Latest inspection
Feb 25, 2020: No Action Indicated (NAI)
Inspections on record
1 (1 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Feb 25, 2020No Action Indicated (NAI)Quality audits - auditor independence (21 CFR 820.22)
Lack of or inadequate procedures (21 CFR 820.100(a))
Training records (21 CFR 820.25(b))

Facility details

Company
FCM SMART CENTER GROUP
Location
Odessa, FL (US)
Source
device

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.