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SHILPA PHARMA LIFESCIENCES LIMITED FDA Inspection Record

FEI 3007197995 · Inspections, Form 483s, warning letters and import refusals

SHILPA PHARMA LIFESCIENCES LIMITED is an FDA-registered facility (FEI 3007197995) located in Raichur, IN. Registered operations: ANALYSIS; API MANUFACTURE. RegDataLab tracks 6 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Mar 14, 2025: No Action Indicated (NAI)
Inspections on record
6 (1 OAI, 3 VAI, 2 NAI)
Last OAI inspection
May 3, 2013
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Form 483 and inspection documents
2 in FDA's reading room
Import refusals
3

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Mar 14, 2025No Action Indicated (NAI)No citations listed
Feb 7, 2020No Action Indicated (NAI)No citations listed
Jul 26, 2019Voluntary Action Indicated (VAI)No citations listed
Dec 16, 2016Voluntary Action Indicated (VAI)No citations listed
Mar 9, 2015Voluntary Action Indicated (VAI)No citations listed
May 3, 2013Official Action Indicated (OAI)No citations listed

Form 483s and inspection documents

  • 483 on FDA.gov
    Inspection Jul 22, 2019 to Jul 26, 2019, issued Jul 26, 2019 (dates printed on the document). FDA listing date Jul 26, 2019. Published by FDA Aug 22, 2019.
  • 483 on FDA.gov
    FDA listing date Jan 19, 2018, which is not always the inspection or issue date. Published by FDA Jan 30, 2018.

FDA record score

3 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 14, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

4 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAIJul 26, 20196 x 0.251.5
Inspection classified VAIDec 16, 20166 x 0.251.5
Inspection classified VAIMar 9, 201510 years or older, so it adds no points0
Inspection classified OAIMay 3, 201310 years or older, so it adds no points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
Shilpa Pharma Lifesciences Limited
Location
Raichur (IN)
Registration Expires
Dec 31, 2027
Operations
ANALYSIS; API MANUFACTURE
Source
decrs

Import refusals

FDA data resources

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