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Srikem Laboratories Private Ltd.

FDA Regulatory Profile

Srikem Laboratories Private Ltd. has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 1 compliance action on record.

Latest inspection
May 31, 2024 · OAI

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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
Inspections3Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
May 31, 2024Navi Mumbai, IndiaDrugsOfficial Action Indicated (OAI)3005048741
Dec 18, 2015Navi Mumbai, IndiaDrugsOfficial Action Indicated (OAI)3005048741
Feb 15, 2013Navi Mumbai, IndiaDrugsVoluntary Action Indicated (VAI)3005048741

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 3005048741Navi Mumbai, India3May 31, 2024

FDA data resources

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