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Temmentech AG — FDA Facility Profile

FEI 3004577394

Temmentech AG is an FDA-inspected facility (FEI 3004577394) located in Sumiswald, CH. RegDataLab tracks 1 FDA inspection at this facility.

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What FDA found at this site

Latest inspection
Jun 17, 2016: Official Action Indicated (OAI)
Inspections on record
1 (1 OAI)
Last OAI inspection
Jun 17, 2016
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Import refusals
1

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
Jun 17, 2016Official Action Indicated (OAI)Equipment Design, Size and Location (21 CFR 211.63)
Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a))
Written procedures not established/followed (21 CFR 211.67(b))
Computer control of master formula records (21 CFR 211.68(b))
and 8 more

Facility details

Company
Temmentech AG
Location
Sumiswald (CH)
Source
inspections

Import refusals

FDA data resources

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