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Laurus Labs Limited

FDA Regulatory Profile

Laurus Labs Limited has 0 FDA recalls, 13 inspections, 0 510(k) clearances and 0 compliance actions on record.

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

Latest inspection: Jan 31, 2025 · VAI

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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	13	Nov 13, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Laurus Labs 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	2	0	0	0	0
2023	1	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	2	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

13 inspections from Oct 29, 2009 to Jan 31, 2025.

Date	Site	Product	Classification	FEI
Jan 31, 2025	Lalam Koduru, India	Drugs	Voluntary Action Indicated (VAI)	3014255847
Sep 13, 2024	Medchal-Malkajgiri, India	Drugs	No Action Indicated (NAI)	3006527015
Apr 19, 2024	Anikapalli District, India	Drugs	No Action Indicated (NAI)	3007083664
Feb 10, 2023	Anakapalli, India	Drugs	Voluntary Action Indicated (VAI)	3011538548
Jul 12, 2019	Lalam Koduru, India	Drugs	No Action Indicated (NAI)	3014255847
Jun 14, 2019	Anikapalli District, India	Drugs	Voluntary Action Indicated (VAI)	3007083664
Aug 18, 2017	Anikapalli District, India	Drugs	Voluntary Action Indicated (VAI)	3007083664
May 19, 2017	Anakapalli, India	Drugs	No Action Indicated (NAI)	3011538548
Jun 24, 2016	Medchal-Malkajgiri, India	Drugs	No Action Indicated (NAI)	3006527015
Apr 24, 2015	Anikapalli District, India	Drugs	No Action Indicated (NAI)	3007083664
Apr 25, 2014	Medchal-Malkajgiri, India	Drugs	Voluntary Action Indicated (VAI)	3006527015
Nov 27, 2012	Anikapalli District, India	Drugs	Voluntary Action Indicated (VAI)	3007083664
Oct 29, 2009	Anikapalli District, India	Drugs	No Action Indicated (NAI)	3007083664

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

4 inspected sites, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3014255847	Lalam Koduru, India	2	Jan 31, 2025
FEI 3006527015	Medchal-Malkajgiri, India	3	Sep 13, 2024
FEI 3007083664	Anikapalli District, India	6	Apr 19, 2024
FEI 3011538548	Anakapalli, India	2	Feb 10, 2023

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