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Embio Limited FDA Record

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

Embio Limited has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Embio Limited" is on file.

What these totals cover: FDA records filed under the name "Embio Limited".

Latest inspection: May 2, 2025 · 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 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Embio Limited'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	1	0	0	0	0
2024	0	0	0	0	0
2023	0	0	0	0	0
2022	0	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	0	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 6, 2012 to May 2, 2025.

Date	Site	Product	Classification	FEI
May 2, 2025	Mahad, India	Drugs	No Action Indicated (NAI)	1000283831
Jan 31, 2019	Mahad, India	Drugs	No Action Indicated (NAI)	1000283831
Apr 21, 2016	Mahad, India	Drugs	No Action Indicated (NAI)	1000283831
Jun 6, 2012	Mahad, India	Drugs	Voluntary Action Indicated (VAI)	1000283831

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.

Facility	Location	Inspections	Latest
FEI 1000283831	Mahad, India	4	May 2, 2025

Embio Limited and the FDA: common questions

Has Embio Limited received an FDA warning letter?

No FDA warning letter addressed to the name "Embio Limited" 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 Embio Limited received an FDA Form 483?

FDA has not published a Form 483 for "Embio Limited" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Embio Limited?

The most recent FDA inspection on file ended May 2, 2025 at Mahad, India and was classified NAI. FDA has 4 inspections of Embio Limited on file.

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