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Rotem Industries Ltd. — FDA Facility Profile

FEI 3008739573

Rotem Industries Ltd. is an FDA-registered facility (FEI 3008739573) located in Dimona, IL. Registered operations: API MANUFACTURE. RegDataLab tracks 3 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Nov 7, 2019: Voluntary Action Indicated (VAI)
Inspections on record
3 (3 VAI)
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
Import refusals
3

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 7, 2019Voluntary Action Indicated (VAI)No citations listed
Nov 12, 2015Voluntary Action Indicated (VAI)No citations listed
Nov 29, 2012Voluntary Action Indicated (VAI)No citations listed

Facility details

Company
Rotem Industries Limited
Location
Dimona (IL)
Registration Expires
Dec 31, 2027
Operations
API MANUFACTURE
Source
decrs

Import refusals

FDA data resources

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