Maithri Laboratories Private Limited FDA Record

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

Maithri Laboratories Private Limited has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Maithri Laboratories Private Limited" is on file.

What these totals cover: FDA records filed under the name "Maithri Laboratories Private Limited".

Latest inspection
May 2, 2025 · VAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections3Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

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

Maithri Laboratories Private Limited: FDA inspections per year 2017: 0 inspections020172018: 0 inspections020182019: 1 inspections120192020: 0 inspections020202021: 0 inspections020212022: 0 inspections020222023: 0 inspections020232024: 0 inspections020242025: 1 inspections120252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202510000
202400000
202300000
202200000
202100000
202000000
201910000
201800000
201700000

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

3 inspections from Jun 26, 2012 to May 2, 2025.

DateSiteProductClassificationFEI
May 2, 2025Sangareddy, IndiaDrugsVoluntary Action Indicated (VAI)3007800082
May 31, 2019Sangareddy, IndiaDrugsNo Action Indicated (NAI)3007800082
Jun 26, 2012Sangareddy, IndiaDrugsNo Action Indicated (NAI)3007800082
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.

FacilityLocationInspectionsLatest
FEI 3007800082Sangareddy, India3May 2, 2025

Maithri Laboratories Private Limited and the FDA: common questions

Has Maithri Laboratories Private Limited received an FDA warning letter?

No FDA warning letter addressed to the name "Maithri Laboratories Private Limited" 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 Maithri Laboratories Private Limited received an FDA Form 483?

FDA has not published a Form 483 for "Maithri Laboratories Private Limited" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Maithri Laboratories Private Limited?

The most recent FDA inspection on file ended May 2, 2025 at Sangareddy, India and was classified VAI. FDA has 3 inspections of Maithri Laboratories Private Limited on file.

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.