# FDA 483 - Startech Labs Private Limited - February 15, 2016

Source: https://www.globalkeysolutions.net/records/483/startech-labs-private-limited/96a52712-3101-44b3-9040-07d40efadaa9

> FDA 483 for Startech Labs Private Limited on February 15, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Startech Labs Private Limited
- Inspection Date: 2016-02-15
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of M/S Startech Labs Private Limited, a control testing laboratory in Hyderabad, revealed two significant observations. The firm was cited for issues related to method validation, specifically that analysts performing a particle size distribution validation were not present on site. Additionally, the inspection found that employees were not trained according to the established training schedule.

## Related Documents

- [483 - 2017-08-09](https://www.globalkeysolutions.net/records/483/startech-labs-private-limited/74d1547d-ab03-42cb-aad6-9f7ca3b31dbd)

## Related Officers

- [Satheesh Thomas](https://www.globalkeysolutions.net/people/satheesh-thomas/8009b8a5-40f5-4791-b0e9-a7c855e3afd4)

Company: https://www.globalkeysolutions.net/companies/startech-labs-private-limited/5b8d2854-5f66-493a-a811-1ead749c6cb4

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