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Gland Pharma Limited

FDA Regulatory Profile

Gland Pharma Limited has 0 FDA recalls, 25 inspections, 0 510(k) clearances and 0 compliance actions on record.

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

Latest inspection: Jul 25, 2024 · 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	25	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

Gland Pharma 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	0	0	0	0	0
2024	2	0	0	0	0
2023	5	0	0	0	0
2022	1	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	3	0	0	0	0
2018	4	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

25 inspections from Jan 7, 2011 to Jul 25, 2024. Showing the 20 most recent. View all 25 inspections

Date	Site	Product	Classification	FEI
Jul 25, 2024	Hyderabad, India	Drugs	Voluntary Action Indicated (VAI)	3002647489
May 24, 2024	Parawada, Anakapalli, India	Drugs	No Action Indicated (NAI)	3010142300
Aug 26, 2023	Sangareddy District, Hyderabad, India	Devices	Voluntary Action Indicated (VAI)	3009864167
Jul 28, 2023	Visakhapatnam, India	Drugs	No Action Indicated (NAI)	3009056604
Jul 14, 2023	Hyderabad, India	Drugs	Voluntary Action Indicated (VAI)	3002647489
Jun 27, 2023	Sangareddy District, Hyderabad, India	Drugs	Voluntary Action Indicated (VAI)	3009864167
Jan 27, 2023	Parawada, Anakapalli, India	Drugs	No Action Indicated (NAI)	3010142300
Aug 25, 2022	Hyderabad, India	Devices	Voluntary Action Indicated (VAI)	3002647489
Nov 7, 2019	Sangareddy District, Hyderabad, India	Drugs	Voluntary Action Indicated (VAI)	3009864167
Nov 1, 2019	Visakhapatnam, India	Drugs	Voluntary Action Indicated (VAI)	3009056604
May 16, 2019	Hyderabad, India	Drugs	Voluntary Action Indicated (VAI)	3002647489
Jun 15, 2018	Visakhapatnam, India	Drugs	No Action Indicated (NAI)	3009056604
May 18, 2018	Visakhapatnam, India	Drugs	No Action Indicated (NAI)	3009056604
Apr 20, 2018	Parawada, Anakapalli, India	Drugs	Voluntary Action Indicated (VAI)	3010142300
Feb 23, 2018	Sangareddy District, Hyderabad, India	Drugs	Voluntary Action Indicated (VAI)	3009864167
Mar 31, 2017	Visakhapatnam, India	Drugs	No Action Indicated (NAI)	3009056604
Feb 3, 2017	Hyderabad, India	Drugs	Voluntary Action Indicated (VAI)	3002647489
Oct 29, 2015	Parawada, Anakapalli, India	Drugs	No Action Indicated (NAI)	3010142300
Sep 18, 2015	Sangareddy District, Hyderabad, India	Drugs	Voluntary Action Indicated (VAI)	3009864167
Jun 30, 2015	Visakhapatnam, India	Drugs	Voluntary Action Indicated (VAI)	3009056604

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 3002647489	Hyderabad, India	8	Jul 25, 2024
FEI 3010142300	Parawada, Anakapalli, India	4	May 24, 2024
FEI 3009864167	Sangareddy District, Hyderabad, India	5	Aug 26, 2023
FEI 3009056604	Visakhapatnam, India	8	Jul 28, 2023

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