Site records / Madhya Pradesh / FEI 3010453141

Mylan Laboratories LimitedDistrict - Dhar, Madhya Pradesh

FDA-registered drug establishment in District - Dhar, Madhya Pradesh: analysis, label, manufacture, pack. Registration valid to 31 Dec 2026. Record as observed 27 Sep 2026.

Inspections posted: 3
Last inspection: May 2019 · NAI
Warning letters to this FEI: 1
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

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

24 May 2019NAI · No Action IndicatedDrug Quality Assurance · no citations posted
5 Feb 2016VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
14 Mar 2014VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted

Warning letters and compliance actions

19 Dec 2024Warning Letter · CDER SourceCGMP/Finished Pharmaceuticals/Adulterated
6 Aug 2015Warning letter to Mylan Laboratories Limited SourceCGMP/Finished Pharmaceuticals/Adulterated · issued to the firm name; FDA does not tie it to this FEI

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.

19 Dec 2024Import alert 66-40 · Published address is this site SourcePublished address: (FDF-3) Plot Nos. 11, 12, 13, Indore SEZ , Pharma Zone, Phase II, Sector III , Pithampur, District Dhar, Madhya Pradesh INDIA

Form 483s released by FDA

26 Jun 2024Form 483 · 18 pages Source

Other registered sites of Viatris Inc.

Mylan Laboratories LimitedNashik, Maharashtra
Mylan Laboratories LimitedHyderabad, Telangana
Mylan Laboratories LimitedBangalore, Karnataka
Mylan Laboratories LimitedBengaluru, Karnataka
Mylan Laboratories LimitedHyderabad, Telangana
Mylan Laboratories LimitedHosur, Tamil Nadu
Mylan Laboratories LimitedChhatrapati Sambhajinagar, Maharashtra

Registration

FEI: 3010453141
DUNS: 859649433
Registered as: Mylan Laboratories Limited
Registrant: Viatris Inc.
Address: (FDF-3) Plot No. 11, 12 &13, Indore Special Economic Zone Pharma Zone, Phase II, Sector III Pithampur, District - Dhar, Madhya Pradesh 454775, India (IND)
Operations: ANALYSIS, LABEL, 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.