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Dexcel Ltd.

FDA Regulatory Profile

Dexcel Ltd. has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 1 compliance action on record.

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

Latest inspection: Dec 14, 2022 · NAI

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Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	4	Nov 13, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA Record by Year

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

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	0	0	0	0	0
2024	0	0	0	0	0
2023	0	0	0	0	0
2022	1	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	1	0	0	0	0
2018	0	0	0	0	0
2017	1	0	0	0	0

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.

Recent FDA Inspections

4 inspections from Jun 5, 2013 to Dec 14, 2022.

Date	Site	Product	Classification	FEI
Dec 14, 2022	Or Akiva, Israel	Drugs	No Action Indicated (NAI)	3002806801
Jul 24, 2019	Or Akiva, Israel	Drugs	Voluntary Action Indicated (VAI)	3002806801
Feb 16, 2017	Or Akiva, Israel	Drugs	Voluntary Action Indicated (VAI)	3002806801
Jun 5, 2013	Or Akiva, Israel	Drugs	No Action Indicated (NAI)	3002806801

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means 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.

Facility	Location	Inspections	Latest
FEI 3002806801	Or Akiva, Israel	4	Dec 14, 2022

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