# FDA 483 - Dasami Lab Private Limited - June 01, 2018

Source: https://www.keypedia.com/records/483/dasami-lab-private-limited/68e72216-4e16-408a-b078-cd580eaaaa85

> FDA 483 for Dasami Lab Private Limited on June 01, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dasami Lab Private Limited
- Inspection Date: 2018-06-01
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Dasami Lab Private Limited, an API manufacturer, was inspected by the FDA and received a Form 483 with four observations. The inspection revealed deficiencies in stability data for drug substances, lack of equipment log books, inadequate analytical method transfers and verifications, and an insufficient power failure procedure. These issues indicate a need for improved quality control and documentation practices.

## Related Documents

- [483 - 2018-06-01](https://www.keypedia.com/records/483/dasami-lab-private-limited/600e9380-e109-425b-9d0c-b154fee23acc)

## Related Officers

- [Uttaniti Limchumroon](https://www.keypedia.com/people/uttaniti-limchumroon/ce890cbf-2f5c-498f-917c-0edf8b10d356)

Company: https://www.keypedia.com/companies/dasami-lab-private-limited/950d9812-d647-4e9e-ad9a-01eab0ebe091

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1