# FDA 483 - Daicel Chiral Technologies (India) Private Limited - February 10, 2016

Source: https://www.keypedia.com/records/483/daicel-chiral-technologies-india-private-limited/5275247a-2f33-4d5f-8f6d-7db4d74c643e

> FDA 483 for Daicel Chiral Technologies (India) Private Limited on February 10, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Daicel Chiral Technologies (India) Private Limited
- Inspection Date: 2016-02-10
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Daicel Chiral Technologies (India) Private Limited, a control testing laboratory, revealed deficiencies in employee training and attendance record-keeping. Specifically, employees signed training logs for dates they were not present, and attendance registers showed unauthorized alterations. Additionally, GMP training was not conducted with sufficient frequency to ensure ongoing compliance.

## Related Officers

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

Company: https://www.keypedia.com/companies/daicel-chiral-technologies-india-private-limited/45c91172-d6b1-4c1b-a405-8634d7314a7e

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