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Kalintis Healthcare Private Ltd. FDA Record

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

Latest inspection NAI · Oct 17, 2025
No warning letters matched by name

Inspections 2

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

Kalintis Healthcare Private Ltd. has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Kalintis Healthcare Private Ltd." is on file.

What these totals cover: FDA records filed under the name "Kalintis Healthcare Private Ltd." and its spelling variant "Kalintis Healthcare Private".

Latest inspection: Oct 17, 2025 · NAI

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	2	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

Kalintis Healthcare Private Ltd.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Kalintis Healthcare Private Ltd.: FDA inspections per year

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	0	0	0	0	0
2018	1	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

2 inspections from Dec 14, 2018 to Oct 17, 2025.

Date	Site	Product	Classification	FEI
Oct 17, 2025	Savli, India	Drugs	No Action Indicated (NAI)	3013455974
Dec 14, 2018	Savli, India	Drugs	No Action Indicated (NAI)	3013455974

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

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3013455974	Savli, India	2	Oct 17, 2025

Kalintis Healthcare Private Ltd. and the FDA: common questions

Has Kalintis Healthcare Private Ltd. received an FDA warning letter?

No FDA warning letter addressed to the name "Kalintis Healthcare Private Ltd." 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 Kalintis Healthcare Private Ltd. received an FDA Form 483?

FDA has not published a Form 483 for "Kalintis Healthcare Private Ltd." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Kalintis Healthcare Private Ltd.?

The most recent FDA inspection on file ended Oct 17, 2025 at Savli, India and was classified NAI. FDA has 2 inspections of Kalintis Healthcare Private Ltd. on file.

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