# FDA 483 - Valens Molecules Private Limited - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/valens-molecules-private-limited/1ea21e06-a562-4af9-8dd2-afbd1ab20e18

> FDA 483 for Valens Molecules Private Limited on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Valens Molecules Private Limited
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: An FDA inspection of Posh Chemicals Private, Ltd. in Hyderabad, India, an API manufacturer, from March 30 to April 06, 2015, revealed significant deficiencies across multiple areas. The firm exhibited inadequate employee training, a lack of validation for test methods and laboratory equipment, and poor laboratory controls. These observations indicate a systemic failure to adhere to current Good Manufacturing Practices, posing a risk to the quality and purity of drug substances.

## Related Documents

- [483 - 2024-09-13](https://www.globalkeysolutions.net/records/483/valens-molecules-private-limited/92298f92-f07d-42a4-88ef-65562273fca9)

## Related Officers

- [sharon.thoma@fda.gov](https://www.globalkeysolutions.net/people/sharon-k-thoma/d72ee980-45a4-4f2c-9b1e-e29798492e7d)
- [Jose R. Lopez](https://www.globalkeysolutions.net/people/jose-r-lopez/f4e8e5fa-4765-4d8b-828d-32c202f8dadc)

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

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321