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Enaltec Labs Private Limited FDA Record

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

Enaltec Labs Private Limited has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Enaltec Labs Private Limited" is on file.

What these totals cover: FDA records filed under the name "Enaltec Labs Private Limited".

Latest inspection: Mar 27, 2025 · VAI

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	5	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

Enaltec Labs Private 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	2	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.

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Recent FDA inspections

5 inspections from Aug 8, 2013 to Mar 27, 2025.

Date	Site	Product	Classification	FEI
Mar 27, 2025	Kalyan, India	Drugs	Voluntary Action Indicated (VAI)	3006599894
Jul 26, 2019	Kalyan, India	Drugs	Voluntary Action Indicated (VAI)	3006599894
Feb 27, 2019	Thane, India	Drugs	Voluntary Action Indicated (VAI)	3008912864
Nov 10, 2015	Kalyan, India	Drugs	Voluntary Action Indicated (VAI)	3006599894
Aug 8, 2013	Kalyan, India	Drugs	No Action Indicated (NAI)	3006599894

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

2 inspected sites, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3006599894	Kalyan, India	4	Mar 27, 2025
FEI 3008912864	Thane, India	1	Feb 27, 2019

Enaltec Labs Private Limited and the FDA: common questions

Has Enaltec Labs Private Limited received an FDA warning letter?

No FDA warning letter addressed to the name "Enaltec Labs Private 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 Enaltec Labs Private Limited received an FDA Form 483?

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

When did the FDA last inspect Enaltec Labs Private Limited?

The most recent FDA inspection on file ended Mar 27, 2025 at Kalyan, India and was classified VAI. FDA has 5 inspections of Enaltec Labs Private Limited on file.

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