TECOMET — FDA Facility Profile

FEI 3003018882

TECOMET is an FDA-registered facility (FEI 3003018882) located in Woburn, MA, US. RegDataLab tracks 5 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Nov 12, 2024: No Action Indicated (NAI)
Inspections on record
5 (2 VAI, 3 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
Nov 12, 2024No Action Indicated (NAI)Lack of or inadequate procedures (21 CFR 820.100(a))
Lack of procedures, or not maintained (21 CFR 820.40)
Jan 17, 2020No Action Indicated (NAI)No citations listed
Aug 19, 2015Voluntary Action Indicated (VAI)Complaints (21 CFR 820.198(a))
Documentation of disposition, justification, signature (21 CFR 820.90(b)(1))
May 13, 2010No Action Indicated (NAI)No citations listed
Dec 23, 2008Voluntary Action Indicated (VAI)DHR content (21 CFR 820.184)
Analysis of data sources (21 CFR 820.100(a)(1))
Production processes (21 CFR 820.70(a))

Facility details

Company
Tecomet, Inc.
Location
Woburn, MA (US)
Source
device

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