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SMS Pharmaceuticals Limited

FDA Regulatory Profile

SMS Pharmaceuticals Limited has 0 FDA recalls, 10 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Dec 12, 2025 · OAI

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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
Inspections10Nov 11, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Dec 12, 2025Vizianagaram, IndiaDrugsOfficial Action Indicated (OAI)3008654585
Jun 25, 2025Hyderabad, IndiaDrugsNo Action Indicated (NAI)3014615000
Mar 21, 2025Bachupally, Medchal-Malkajgiri District, Hyderabad, IndiaDrugsVoluntary Action Indicated (VAI)3003971663
Mar 5, 2020Hyderabad, IndiaDrugsNo Action Indicated (NAI)3014615000
Jan 17, 2020Vizianagaram, IndiaDrugsVoluntary Action Indicated (VAI)3008654585
Nov 17, 2017Bachupally, Medchal-Malkajgiri District, Hyderabad, IndiaDrugsNo Action Indicated (NAI)3003971663
Apr 24, 2015Vizianagaram, IndiaDrugsNo Action Indicated (NAI)3008654585
Apr 18, 2014Bachupally, Medchal-Malkajgiri District, Hyderabad, IndiaDrugsVoluntary Action Indicated (VAI)3003971663
Jul 27, 2012Vizianagaram, IndiaDrugsNo Action Indicated (NAI)3008654585
Feb 4, 2011Bachupally, Medchal-Malkajgiri District, Hyderabad, IndiaDrugsNo Action Indicated (NAI)3003971663

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 3008654585Vizianagaram, India4Dec 12, 2025
FEI 3014615000Hyderabad, India2Jun 25, 2025
FEI 3003971663Bachupally, Medchal-Malkajgiri District, Hyderabad, India4Mar 21, 2025

FDA data resources

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