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Alkem Laboratories Limited

FDA Regulatory Profile

Alkem Laboratories Limited has 0 FDA recalls, 20 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Mar 27, 2024 · VAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections20Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Mar 27, 2024Tehsil Nalagarh, Baddi, IndiaDrugsVoluntary Action Indicated (VAI)3006370533
Dec 1, 2023Ankleshwar, IndiaDrugsVoluntary Action Indicated (VAI)3008450172
Apr 7, 2023Ankleshwar, IndiaDrugsNo Action Indicated (NAI)3006851796
Feb 21, 2020Tehsil Nalagarh, Baddi, IndiaDrugsVoluntary Action Indicated (VAI)3006370533
Nov 26, 2019Tehsil Nalagarh, Baddi, IndiaDrugsVoluntary Action Indicated (VAI)3006370533
Aug 30, 2019Daman, IndiaDrugsNo Action Indicated (NAI)3006370524
May 17, 2019Tehsil Nalagarh, Baddi, IndiaDrugsVoluntary Action Indicated (VAI)3006370533
Jan 18, 2019Daman, IndiaDrugsNo Action Indicated (NAI)3006370524
Mar 27, 2018Daman, IndiaDrugsVoluntary Action Indicated (VAI)3006370524
Mar 10, 2017Tehsil Nalagarh, Baddi, IndiaDrugsVoluntary Action Indicated (VAI)3006370533
Dec 9, 2016Ankleshwar, IndiaDrugsVoluntary Action Indicated (VAI)3006851796
Sep 29, 2016Daman, IndiaDrugsVoluntary Action Indicated (VAI)3006370524
Sep 18, 2015Ankleshwar, IndiaDrugsVoluntary Action Indicated (VAI)3008450172
Jul 31, 2015Tehsil Nalagarh, Baddi, IndiaDrugsVoluntary Action Indicated (VAI)3006370533
Nov 23, 2013Ankleshwar, IndiaDrugsVoluntary Action Indicated (VAI)3006851796
Oct 25, 2013Daman, IndiaDrugsVoluntary Action Indicated (VAI)3006370524
Sep 20, 2013Tehsil Nalagarh, Baddi, IndiaDrugsNo Action Indicated (NAI)3006370533
Aug 31, 2012Tehsil Nalagarh, Baddi, IndiaDrugsNo Action Indicated (NAI)3006370533
Dec 9, 2011Daman, IndiaDrugsVoluntary Action Indicated (VAI)3006370524
Nov 6, 2009Tehsil Nalagarh, Baddi, IndiaDrugsVoluntary Action Indicated (VAI)3006370533

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 3006370533Tehsil Nalagarh, Baddi, India9Mar 27, 2024
FEI 3008450172Ankleshwar, India2Dec 1, 2023
FEI 3006851796Ankleshwar, India3Apr 7, 2023
FEI 3006370524Daman, India6Aug 30, 2019

FDA data resources

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