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Granules India Limited

FDA Regulatory Profile

Granules India Limited has 1 FDA recall, 20 inspections, 0 510(k) clearances and 1 compliance action on record.

Latest recall
D-0632-2020 · Class II · Dec 13, 2019
Latest inspection
Jun 20, 2025 · VAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls1Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections20Nov 11, 2026Newest record Nov 5, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Recent Recalls

NumberClassProductDate
D-0632-2020Class IIRANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-773-32Dec 13, 2019

Recent FDA Inspections

DateSiteProductClassificationFEI
Jun 20, 2025Sangareddy District, IndiaDrugsVoluntary Action Indicated (VAI)3003723146
Apr 12, 2024Parawada Mandal, IndiaDrugsNo Action Indicated (NAI)3012884557
Jun 30, 2023Visakhapatnam, IndiaDrugsNo Action Indicated (NAI)3006583291
Jun 23, 2023Secunderabad, IndiaDrugsNo Action Indicated (NAI)3001319869
Feb 14, 2020Medchal-Malkhajgiri District, IndiaDrugsVoluntary Action Indicated (VAI)3004097901
Jan 16, 2020Parawada Mandal, IndiaDrugsVoluntary Action Indicated (VAI)3012884557
Jul 26, 2019Sangareddy District, IndiaDrugsVoluntary Action Indicated (VAI)3003723146
Mar 23, 2018Secunderabad, IndiaDrugsVoluntary Action Indicated (VAI)3001319869
Mar 23, 2018Medchal-Malkhajgiri District, IndiaDrugsNo Action Indicated (NAI)3004097901
Oct 14, 2016Medchal-Malkhajgiri District, IndiaDrugsNo Action Indicated (NAI)3004097901
Dec 18, 2015Secunderabad, IndiaDrugsVoluntary Action Indicated (VAI)3001319869
Dec 18, 2015Visakhapatnam, IndiaDrugsNo Action Indicated (NAI)3006583291
Mar 13, 2015Medchal-Malkhajgiri District, IndiaDrugsNo Action Indicated (NAI)3004097901
Jun 13, 2014Sangareddy District, IndiaDrugsNo Action Indicated (NAI)3003723146
Jun 14, 2013Visakhapatnam, IndiaDrugsNo Action Indicated (NAI)3006583291
May 8, 2013Secunderabad, IndiaDrugsVoluntary Action Indicated (VAI)3001319869
Sep 13, 2012Medchal-Malkhajgiri District, IndiaDrugsVoluntary Action Indicated (VAI)3004097901
Nov 22, 2010Sangareddy District, IndiaDrugsNo Action Indicated (NAI)3003723146
Nov 12, 2009Medchal-Malkhajgiri District, IndiaDrugsNo Action Indicated (NAI)3004097901
Mar 6, 2009Secunderabad, IndiaDrugsVoluntary Action Indicated (VAI)3001319869

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3003723146Sangareddy District, India4Jun 20, 2025
FEI 3012884557Parawada Mandal, India2Apr 12, 2024
FEI 3006583291Visakhapatnam, India3Jun 30, 2023
FEI 3001319869Secunderabad, India5Jun 23, 2023
FEI 3004097901Medchal-Malkhajgiri District, India6Feb 14, 2020

FDA data resources

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