Site records / Karnataka / FEI 3007648351
Mylan Laboratories LimitedBengaluru, Karnataka
FDA-registered drug establishment in Bengaluru, Karnataka: analysis, label, manufacture, pack, sterilize. Registration valid to 31 Dec 2026. Record as observed 27 Sep 2026.
- Inspections posted
- 8
- Last inspection
- Feb 2023 · NAI
- Warning letters to this FEI
- 2
- Import alerts at this address
- 0 of 1 under the name
- US border refusals, 2 years
- 0
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
8 FDA inspections of this FEI, by end date; 8 with a posted classification.
- 24 Feb 2023NAI · No Action IndicatedDrug Quality Assurance · no citations posted
- 28 Feb 2020VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 13 May 2019VAI · Voluntary Action IndicatedDrug Quality Assurance · 12 citations posted
- 2 Mar 2018VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 18 Apr 2017VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 13 Apr 2016VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 3 Oct 2014OAI · Official Action IndicatedDrug Quality Assurance · no citations posted
- 27 Jun 2013OAI · Official Action IndicatedDrug Quality Assurance · no citations posted
Warning letters and compliance actions
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 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
Other registered sites of Viatris Inc.
- Mylan Laboratories LimitedNashik, Maharashtra
- Mylan Laboratories LimitedHyderabad, Telangana
- Mylan Laboratories LimitedBangalore, Karnataka
- Mylan Laboratories LimitedHyderabad, Telangana
- Mylan Laboratories LimitedHosur, Tamil Nadu
- Mylan Laboratories LimitedChhatrapati Sambhajinagar, Maharashtra
- Mylan Laboratories LimitedDistrict - Dhar, Madhya Pradesh
Registration
- FEI
- 3007648351
- DUNS
- 677605290
- Registered as
- Mylan Laboratories Limited
- Registrant
- Viatris Inc.
- Address
- Specialty Formulation Facility, Plot No: 284B/1, 289-292 Bommasandra-Jigani Link Road, Industrial Area, Anekal Taluk, Bengaluru, Karnataka 560105, India (IND)
- Operations
- ANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE
- 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.