Site records / Tamil Nadu / FEI 3005035920

Caplin Steriles LimitedGummidipoondi, Tamil Nadu

FDA-registered drug establishment in Gummidipoondi, Tamil Nadu: analysis, manufacture, pack. Registration valid to 31 Dec 2026. Record as observed 27 Sep 2026.

Inspections posted: 4
Last inspection: Aug 2024 · NAI
Warning letters to this FEI: 0
Import alerts at this address: 1
US border refusals, 2 years: 6

The site dossier

This site, graded.
Every fact sourced.

A grade from A to E on a registered ten-factor rubric, with the fact behind every factor
Every posted FDA citation, sorted into failure categories and set against Indian drug inspections
Warning-letter violations, numbered and labelled
Import-alert history rebuilt from the archive, each listing checked against this address
Border refusals by product, and the company's other sites, each graded
A hash of every source read, so the PDF can be checked against the record

On 2022–26 inspections the rubric never saw, grade E sites were classified OAI 26.5% of the time and grade A sites 4.0%.

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Inspections

4 FDA inspections of this FEI, by end date; 4 with a posted classification.

9 Aug 2024NAI · No Action IndicatedBioresearch Monitoring · no citations posted
31 May 2023VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
14 Jun 2019VAI · Voluntary Action IndicatedDrug Quality Assurance · 2 citations posted
6 Sep 2018NAI · No Action IndicatedDrug Quality Assurance · no citations posted

Warning letters and compliance actions

No FDA compliance action recorded against this FEI or letter to its name.

Import alerts in force

Import-alert pages list a firm name and an address, never an FEI. Each listing under this firm's name is shown with the address FDA published and whether it is this site's.

30 Jun 2014Import alert 66-41 · Published address is this site SourceDetention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.Published address: 895 - 897 Guruvarajakandigai , Survey No 895 - 897 , Gummidipoondi, Tamil Nadu INDIA

Registration

FEI: 3005035920
DUNS: 650744670
Registered as: CAPLIN STERILES LIMITED
Registrant: CAPLIN STERILES LIMITED
Address: SURVEY No.895 & 897. GURUVARAJAKANDIGAI, SIRUPUZHALPETTAI (POST), THIRUVALLUR (DISTRICT), GUMMIDIPOONDI, TAMIL NADU 601201, India (IND)
Operations: ANALYSIS, MANUFACTURE, PACK
Registration expires: 31 Dec 2026

Sources: FDA drug establishment registrations, FDA Data Dashboard inspections and compliance actions, import-alert pages, warning letters, import refusals and the FDA reading room, as held in Counterfoil's point-in-time corpus. No matched action does not establish compliance, and FDA registration is not FDA approval. Sources and coverage.