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Vital Laboratories Pvt Ltd Plant II FDA Record

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

Latest inspection OAI · Sep 1, 2018
Last warning letter 2017

Inspections 3

2 OAI

Recalls 0 0 Class I

Warning letters 1 Latest Oct 11, 2017

510(k) clearances 0 None on file

Vital Laboratories Pvt Ltd Plant II has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Vital Laboratories Pvt Ltd Plant II, the most recent on Oct 11, 2017.

What these totals cover: FDA records filed under the name "Vital Laboratories Pvt Ltd Plant II".

Latest inspection: Sep 1, 2018 · OAI

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

Vital Laboratories Pvt Ltd Plant II's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Vital Laboratories Pvt Ltd Plant II: FDA inspections per year

Year	Inspections	OAI	Warning letters
2026	0	0	0
2025	0	0	0
2024	0	0	0
2023	0	0	0
2022	0	0	0
2021	0	0	0
2020	0	0	0
2019	0	0	0
2018	1	1	0
2017	1	1	1

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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Vital Laboratories Pvt Ltd Plant II FDA Warning Letters

1 warning letter on Oct 11, 2017.

Issued	Subject	Issuing office	Close-out letter
Oct 11, 2017 · 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 25, 2013 to Sep 1, 2018.

Date	Site	Product	Classification	FEI
Sep 1, 2018	Vapi, India	Drugs	Official Action Indicated (OAI)	3007474872
Apr 6, 2017	Vapi, India	Drugs	Official Action Indicated (OAI)	3007474872
Oct 25, 2013	Vapi, India	Drugs	Voluntary Action Indicated (VAI)	3007474872

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 Vital Laboratories Pvt Ltd Plant II: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Oct 11, 2017.

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 3007474872	Vapi, India	3	Sep 1, 2018

Vital Laboratories Pvt Ltd Plant II and the FDA: common questions

Has Vital Laboratories Pvt Ltd Plant II received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Vital Laboratories Pvt Ltd Plant II. The most recent is dated Oct 11, 2017.

Has Vital Laboratories Pvt Ltd Plant II received an FDA Form 483?

FDA has not published a Form 483 for "Vital Laboratories Pvt Ltd Plant II" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Vital Laboratories Pvt Ltd Plant II?

The most recent FDA inspection on file ended Sep 1, 2018 at Vapi, India and was classified OAI. FDA has 3 inspections of Vital Laboratories Pvt Ltd Plant II on file, 2 of them classified OAI (official action indicated).

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