Dexcel Pharma Technologies - Yokneam Factory — FDA Facility Profile

FEI 3008404887

Dexcel Pharma Technologies - Yokneam Factory is an FDA-registered facility (FEI 3008404887) located in Yokneam Illit, IL. Registered operations: LABEL; MANUFACTURE; PACK. RegDataLab tracks 3 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Jul 17, 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 17, 2019Voluntary Action Indicated (VAI)Calibration/Inspection/Checking not done (21 CFR 211.68(a))
Test methods (21 CFR 211.165(e))
Batch production and Batch Control Record Requirements (21 CFR 211.188(b))
Measured components for manufacturing (21 CFR 211.101(b))
and 2 more
Feb 25, 2016No Action Indicated (NAI)No citations listed
May 29, 2013No Action Indicated (NAI)No citations listed

Facility details

Company
Dexcel Pharma Technologies - Yokneam Factory
Location
Yokneam Illit (IL)
Registration Expires
Dec 31, 2026
Operations
LABEL; MANUFACTURE; PACK
Source
decrs

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