# FDA 483 - Tianish Laboratories Private Limited - November 28, 2025

Source: https://www.globalkeysolutions.net/records/483/tianish-laboratories-private-limited/fd8cf086-3c5e-4e12-b933-9dc6f93eb621

> FDA 483 for Tianish Laboratories Private Limited on November 28, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tianish Laboratories Private Limited
- Inspection Date: 2025-11-28
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Matrix Pharmacorp Private Limited in Patancheru, India, an API manufacturer, revealed significant deficiencies across multiple quality systems. Observations included inadequate cleaning procedures, unvalidated equipment, a deficient water monitoring system, and a quality unit failing to conduct thorough investigations. The findings indicate a broad lack of control over critical manufacturing processes and quality assurance.

## Related Documents

- [483 - 2020-02-28](https://www.globalkeysolutions.net/records/483/tianish-laboratories-private-limited/4fd4c4c8-902d-4332-9d2f-c303b655392e)
- [483 - 2022-09-13](https://www.globalkeysolutions.net/records/483/tianish-laboratories-private-limited/7f45d719-db20-49a5-a320-27591070c678)

## Related Officers

- [Youkeun Kim](https://www.globalkeysolutions.net/people/youkeun-kim/94ccfde4-72f7-4df1-9c68-ede73e5e23d0)
- [Drug National Expert](https://www.globalkeysolutions.net/people/sandra-a-boyd/c469103a-0917-407a-b9d1-98273358dfeb)

Company: https://www.globalkeysolutions.net/companies/tianish-laboratories-private-limited/3aa20920-7f85-4cd2-806b-a3cfb4548be8

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8