# Mylan Laboratories Limited - Inspection Records

Source: https://www.keypedia.com/companies/mylan-laboratories-limited/4fd10a2e-3696-4bd0-82aa-e875143028c0

> Inspection records and compliance data for Mylan Laboratories Limited in Sinnar, Nashik, None. Access full analysis and detailed observations.

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## Details

- Name: Mylan Laboratories Limited
- FEI Number: 3005587313
- City: Sinnar, Nashik
- State: None
- Country Name: India
- Address Line 1: (FDF-1), F-4 and F-12, Malegaon MIDC, Pune-Nashik Road
- Zip Code: None
- Facility Type: Finished Drug Product Manufacturer
- Business Operations: API/FDF ANALYTICAL TESTING, FDF MANUFACTURE, IN VITRO BIOEQUIVALENCE OR BIOANALYTICAL TESTING, PACK

## Related Documents

- [483 - Mylan Laboratories Limited - 2026-05-15](https://www.keypedia.com/records/483/mylan-laboratories-limited/ec2d5c33-b1bd-414b-b804-7278b844f215) — source: FDA, date: May 15, 2026
- [483 - Mylan Laboratories Limited - 2024-05-24](https://www.keypedia.com/records/483/mylan-laboratories-limited/5d5281e5-7ee1-42fc-8820-907180cd3e2b) — source: FDA, date: May 24, 2024
- [483 - Mylan Laboratories Limited - 2024-05-24](https://www.keypedia.com/records/483/mylan-laboratories-limited/95a4c8d9-54ca-4f0f-a619-a48676753bea) — source: FDA, date: May 24, 2024
- [FDA Inspection 1238860 - Mylan Laboratories Limited - 2024-05-24](https://www.keypedia.com/records/fda_inspections/mylan-laboratories-limited/eff4ccfb-5f0a-4b77-a91e-fe274e65f52a) — source: FDA, date: May 24, 2024
- [483 - Mylan Laboratories Limited - 2020-02-07](https://www.keypedia.com/records/483/mylan-laboratories-limited/ddc8b37b-414f-413c-9639-04f25dcb98e6) — source: FDA, date: February 7, 2020
- [FDA Inspection 1117137 - Mylan Laboratories Limited - 2020-02-07](https://www.keypedia.com/records/fda_inspections/mylan-laboratories-limited/eb2a6850-c34b-4a44-8331-8e0fe0a71360) — classification: No Action Indicated (NAI), source: FDA, date: February 7, 2020
- [483 - Mylan Laboratories Limited - 2019-01-18](https://www.keypedia.com/records/483/mylan-laboratories-limited/7c112c60-9ef9-405f-9cdf-2e08ef2210f7) — source: FDA, date: January 18, 2019
- [FDA Inspection 1076887 - Mylan Laboratories Limited - 2019-01-18](https://www.keypedia.com/records/fda_inspections/mylan-laboratories-limited/5b34d196-3208-426f-89ab-4191df818396) — classification: No Action Indicated (NAI), source: FDA, date: January 18, 2019
- [483 - Mylan Laboratories Limited - 2018-04-12](https://www.keypedia.com/records/483/mylan-laboratories-limited/4c91fbd7-6c18-41c4-8f08-ca2e411cd51b) — source: FDA, date: April 12, 2018
- [FDA Inspection 1050962 - Mylan Laboratories Limited - 2018-04-12](https://www.keypedia.com/records/fda_inspections/mylan-laboratories-limited/a683e4a0-2bcf-4c26-b5a9-ce56803a8de3) — classification: Voluntary Action Indicated (VAI), source: FDA, date: April 12, 2018
- [483 - Mylan Laboratories Limited - 2016-09-14](https://www.keypedia.com/records/483/mylan-laboratories-limited/6828eda0-b0e4-48e3-a3ef-b71a76c10122) — source: FDA, date: September 14, 2016
- [FDA Inspection 986244 - Mylan Laboratories Limited - 2016-09-14](https://www.keypedia.com/records/fda_inspections/mylan-laboratories-limited/857c5ea1-d989-484a-a710-aa2e084bf02f) — classification: Official Action Indicated (OAI), source: FDA, date: September 14, 2016
- [FDA Inspection 920472 - Mylan Laboratories Limited - 2015-03-25](https://www.keypedia.com/records/fda_inspections/mylan-laboratories-limited/df0db88a-6d48-4bc5-a574-89b81e7f1ffc) — classification: Voluntary Action Indicated (VAI), source: FDA, date: March 25, 2015
- [FDA Inspection 801056 - Mylan Laboratories Limited - 2012-08-30](https://www.keypedia.com/records/fda_inspections/mylan-laboratories-limited/2dd2da63-9e9d-40cd-af38-434d60a668d5) — classification: No Action Indicated (NAI), source: FDA, date: August 30, 2012
- [FDA Inspection 730088 - Mylan Laboratories Limited - 2011-05-27](https://www.keypedia.com/records/fda_inspections/mylan-laboratories-limited/f82b7447-f0e3-41f6-ba7e-1ea55019ad98) — classification: Voluntary Action Indicated (VAI), source: FDA, date: May 27, 2011
- [FDA Inspection 607779 - Mylan Laboratories Limited - 2009-08-08](https://www.keypedia.com/records/fda_inspections/mylan-laboratories-limited/193e1e6a-e506-45c5-9079-a0dd9d693a5b) — classification: No Action Indicated (NAI), source: FDA, date: August 8, 2009

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