Padagis Israel Pharmaceuticals Ltd. FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Padagis Israel Pharmaceuticals Ltd. has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Padagis Israel Pharmaceuticals Ltd." is on file.

What these totals cover: FDA records filed under the name "Padagis Israel Pharmaceuticals Ltd." and its spelling variant "Padagis Israel Pharmaceuticals".

Latest inspection
Sep 20, 2023 · NAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections7Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Padagis Israel Pharmaceuticals Ltd.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Padagis Israel Pharmaceuticals Ltd.: FDA inspections per year 2017: 0 inspections020172018: 1 inspections120182019: 1 inspections120192020: 0 inspections020202021: 0 inspections020212022: 1 inspections120222023: 1 inspections120232024: 0 inspections020242025: 0 inspections020252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202500000
202400000
202310000
202210000
202100000
202000000
201910000
201810000
201700000

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

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Recent FDA inspections

7 inspections from Jan 28, 2010 to Sep 20, 2023.

DateSiteProductClassificationFEI
Sep 20, 2023Yerucham, IsraelDevicesNo Action Indicated (NAI)3001904238
Oct 27, 2022Yerucham, IsraelDrugsNo Action Indicated (NAI)3001904238
Jun 13, 2019Yerucham, IsraelDrugsNo Action Indicated (NAI)3001904238
Jul 19, 2018Yerucham, IsraelDrugsNo Action Indicated (NAI)3001904238
Jan 22, 2015Yerucham, IsraelDrugsVoluntary Action Indicated (VAI)3001904238
Aug 27, 2012Yerucham, IsraelDrugsVoluntary Action Indicated (VAI)3001904238
Jan 28, 2010Yerucham, IsraelDrugsNo Action Indicated (NAI)3001904238
NAI
No objectionable conditions or practices were found during the inspection.
VAI
Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI
Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3001904238Yerucham, Israel7Sep 20, 2023

Padagis Israel Pharmaceuticals Ltd. and the FDA: common questions

Has Padagis Israel Pharmaceuticals Ltd. received an FDA warning letter?

No FDA warning letter addressed to the name "Padagis Israel Pharmaceuticals Ltd." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Padagis Israel Pharmaceuticals Ltd. received an FDA Form 483?

FDA has not published a Form 483 for "Padagis Israel Pharmaceuticals Ltd." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Padagis Israel Pharmaceuticals Ltd.?

The most recent FDA inspection on file ended Sep 20, 2023 at Yerucham, Israel and was classified NAI. FDA has 7 inspections of Padagis Israel Pharmaceuticals Ltd. on file.

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