Home / Companies / Sitec Labs Limited

Sitec Labs Limited

FDA Regulatory Profile

Sitec Labs Limited has 0 FDA recalls, 12 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Apr 23, 2026 · VAI

Reviewing Sitec Labs Limited as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check Sitec Labs Limited yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

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
Inspections12Nov 9, 2026Newest record Oct 28, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Apr 23, 2026Navi Mumbai, IndiaDrugsVoluntary Action Indicated (VAI)3008763840
Feb 20, 2025Navi Mumbai, IndiaDrugsVoluntary Action Indicated (VAI)3008763840
Jun 7, 2024Navi Mumbai, IndiaDrugsVoluntary Action Indicated (VAI)3008763840
Mar 29, 2024Navi Mumbai, IndiaDrugsVoluntary Action Indicated (VAI)3008763840
Nov 25, 2022Navi Mumbai, IndiaDrugsNo Action Indicated (NAI)3008763840
Nov 20, 2019Navi Mumbai, IndiaDrugsNo Action Indicated (NAI)3008763840
Sep 20, 2019Navi Mumbai, IndiaDrugsVoluntary Action Indicated (VAI)3008763840
Aug 22, 2019Mumbai, IndiaDrugsNo Action Indicated (NAI)3005866424
Aug 22, 2019Navi Mumbai, IndiaDrugsNo Action Indicated (NAI)3008763840
Oct 7, 2016Navi Mumbai, IndiaDrugsNo Action Indicated (NAI)3008763840
Apr 30, 2014Navi Mumbai, IndiaDrugsNo Action Indicated (NAI)3008763840
Jun 1, 2011Navi Mumbai, IndiaDrugsNo Action Indicated (NAI)3008763840

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 3008763840Navi Mumbai, India11Apr 23, 2026
FEI 3005866424Mumbai, India1Aug 22, 2019

FDA data resources

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