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Indoco Remedies Limited (Plant I) FDA Record

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

Latest inspection VAI · Jan 20, 2023
Last warning letter 2019

Inspections 3

1 OAI

Recalls 0 0 Class I

Warning letters 1 Latest Jul 9, 2019

510(k) clearances 0 None on file

Indoco Remedies Limited (Plant I) has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Indoco Remedies Limited (Plant I), the most recent on Jul 9, 2019.

What these totals cover: FDA records filed under the name "Indoco Remedies Limited (Plant I)".

Latest inspection: Jan 20, 2023 · 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	3	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Indoco Remedies Limited (Plant I)'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Indoco Remedies Limited (Plant I): FDA inspections per year

Year	Inspections	OAI	Warning letters
2026	0	0	0
2025	0	0	0
2024	0	0	0
2023	1	0	0
2022	0	0	0
2021	0	0	0
2020	0	0	0
2019	0	0	1
2018	1	1	0
2017	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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Indoco Remedies Limited (Plant I) FDA Warning Letters

1 warning letter on Jul 9, 2019.

Issued	Subject	Issuing office	Close-out letter
Jul 9, 2019 · Record page

A warning letter is FDA's formal notice that a company has violated FDA requirements. Each date links to the letter on fda.gov where FDA has it online. Search the text of every letter with the FDA warning letter search.

Recent FDA inspections

3 inspections from Oct 29, 2015 to Jan 20, 2023.

Date	Site	Product	Classification	FEI
Jan 20, 2023	Verna, India	Drugs	Voluntary Action Indicated (VAI)	3006644152
Jan 19, 2018	Verna, India	Drugs	Official Action Indicated (OAI)	3006644152
Oct 29, 2015	Verna, India	Drugs	Voluntary Action Indicated (VAI)	3006644152

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.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under Indoco Remedies Limited (Plant I): warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Jul 9, 2019.

The warning letters in this data are listed above, together with the letters FDA posts online; a letter found in both is shown once. Other actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3006644152	Verna, India	3	Jan 20, 2023

Indoco Remedies Limited (Plant I) and the FDA: common questions

Has Indoco Remedies Limited (Plant I) received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Indoco Remedies Limited (Plant I). The most recent is dated Jul 9, 2019.

Has Indoco Remedies Limited (Plant I) received an FDA Form 483?

FDA has not published a Form 483 for "Indoco Remedies Limited (Plant I)" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Indoco Remedies Limited (Plant I)?

The most recent FDA inspection on file ended Jan 20, 2023 at Verna, India and was classified VAI. FDA has 3 inspections of Indoco Remedies Limited (Plant I) on file, 1 of them classified OAI (official action indicated).

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