Titronics Research & Development — FDA Facility Profile

FEI 3001451268

Titronics Research & Development is an FDA-registered facility (FEI 3001451268) located in TIFFIN, IA, US. RegDataLab tracks 3 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Jul 9, 2019: Voluntary Action Indicated (VAI)
Inspections on record
3 (1 VAI, 2 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
Jul 9, 2019Voluntary Action Indicated (VAI)Procedures not adequately established or maintained (21 CFR 820.40)
Lack of or inadequate DHR procedures (21 CFR 820.184)
Calibration procedures - content (21 CFR 820.72(b))
Nonconforming product, Lack of or inadequate procedures (21 CFR 820.90(a))
Apr 16, 2014No Action Indicated (NAI)Lack of or inadequate complaint procedures (21 CFR 820.198(a))
Quality Audit/Reaudit - conducted (21 CFR 820.22)
Management review - defined interval, sufficient frequency (21 CFR 820.20(c))
Jul 14, 2009No Action Indicated (NAI)No citations listed

Facility details

Company
Titronics Research & Development Co.
Location
TIFFIN, IA (US)
Source
device

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