# FDA 483 - Valens Molecules Private Limited - September 13, 2024

Source: https://www.globalkeysolutions.net/records/483/valens-molecules-private-limited/92298f92-f07d-42a4-88ef-65562273fca9

> FDA 483 for Valens Molecules Private Limited on September 13, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Valens Molecules Private Limited
- Inspection Date: 2024-09-13
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Valens Molecules Private Limited Unit - II, an API manufacturer in Hyderabad, India, was cited for significant deficiencies in its laboratory controls. The inspection revealed a failure to perform required assay testing for drug substances and issues with the preparation and quality control of microbiological media. These findings indicate a lack of scientifically sound test procedures, posing potential risks to the identity, strength, quality, and purity of their drug substances.

## Related Documents

- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/valens-molecules-private-limited/1ea21e06-a562-4af9-8dd2-afbd1ab20e18)

## Related Officers

- [Oluwasefunmi Agbanigo](https://www.globalkeysolutions.net/people/oluwasefunmi-agbanigo/096acae0-9835-4ff1-8faa-c5ec6f551b21)
- [Bijoy Panicker](https://www.globalkeysolutions.net/people/bijoy-panicker/1c6ec57f-e02e-49b8-8b59-1853f3d2947a)

Company: https://www.globalkeysolutions.net/companies/valens-molecules-private-limited/782b14d8-72b3-4782-9a8c-fdf4373bee0b

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