Site records / Maharashtra / FEI 3005587313

Mylan Laboratories LimitedNashik, Maharashtra

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

Inspections posted
8
Last inspection
Feb 2020 · NAI
Warning letters to this FEI
1
Import alerts at this address
0 of 1 under the name
US border refusals, 2 years
1
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%.

PDF and data by email, usually within minutes, as of the day you buy. Card payment through Razorpay.

By buying you agree to the Terms and the refund policy: sales are final once delivered, except non-delivery.

Consultant plan · US$799 a month · five dossiers a month and watchlist alerts. Ask about the plan

Inspections

8 FDA inspections of this FEI, by end date; 8 with a posted classification.

  1. 7 Feb 2020NAI · No Action IndicatedDrug Quality Assurance · no citations posted
  2. 18 Jan 2019NAI · No Action IndicatedDrug Quality Assurance · no citations posted
  3. 12 Apr 2018VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  4. 14 Sep 2016OAI · Official Action IndicatedDrug Quality Assurance · 5 citations posted
  5. 25 Mar 2015VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  6. 30 Aug 2012NAI · No Action IndicatedDrug Quality Assurance · no citations posted
  7. 27 May 2011VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  8. 8 Aug 2009NAI · No Action IndicatedDrug Quality Assurance · no citations posted

Warning letters and compliance actions

  1. 31 Mar 2017Warning Letter · CDER
  2. 19 Dec 2024Warning letter to Viatris, Inc. SourceCGMP/Finished Pharmaceuticals/Adulterated · issued to the firm name; FDA does not tie it to this FEI
  3. 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.

  1. 19 Dec 2024Import alert 66-40 · Published address is another site of this firm 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

  1. 14 Sep 2016Form 483 · 10 pages Source

Other registered sites of Viatris Inc.

Registration

FEI
3005587313
DUNS
725584960
Registered as
Mylan Laboratories Limited
Registrant
Viatris Inc.
Address
(FDF-1), F-4 and F-12, Malegaon MIDC, Sinnar, Nasik District, Nashik, Maharashtra 422113, 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.

COUNTERFOIL / CONTACT

Contact us.

How can we help?

Stored privately by Counterfoil. Your email is used only to respond to your enquiry.