Site records / Maharashtra / FEI 3005048741

Srikem Laboratories Private LimitedNavi Mumbai, Maharashtra

FDA-registered drug establishment in Navi Mumbai, Maharashtra: api manufacture. Registration valid to 31 Dec 2026. Record as observed 27 Sep 2026.

Inspections posted: 3
Last inspection: May 2024 · OAI
Warning letters to this FEI: 1
Import alerts at this address: 1
US border refusals, 2 years: 0

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

3 FDA inspections of this FEI, by end date; 3 with a posted classification.

31 May 2024OAI · Official Action IndicatedDrug Quality Assurance · no citations posted
18 Dec 2015OAI · Official Action IndicatedDrug Quality Assurance · no citations posted
15 Feb 2013VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted

Warning letters and compliance actions

10 Nov 2016Warning Letter · CDER

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.

6 Jul 2016Import alert 66-40 · Published address is this site SourcePublished address: Plot No. 17/22, 17/23, 17/24 & 17/13, MIDC, Taloja, Tal. Panvel, Raigad , Navi Mumbai, Maharashtra INDIA

Registration

FEI: 3005048741
DUNS: 862464427
Registered as: SRIKEM LABORATORIES PRIVATE LIMITED
Registrant: SRIKEM LABORATORIES PRIVATE LIMITED
Address: Plot No. 17/22, 17/23, 17/24 & 17/13, MIDC, Taloja, Tal. Panvel, Raigad, Navi Mumbai, Maharashtra 410208, India (IND)
Operations: API MANUFACTURE
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.