# FDA 483 - Valens Molecules Private Limited - July 29, 2016

Source: https://www.keypedia.com/records/483/valens-molecules-private-limited/0db6ea8b-11a2-4b5b-94e6-e5f9908bf8fc

> FDA 483 for Valens Molecules Private Limited on July 29, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Valens Molecules Private Limited
- Inspection Date: 2016-07-29
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Resh Chemicals Private Limited in Malkajgiri, Hyderabad, India, an API manufacturer, revealed significant deficiencies in their quality systems. Observations included inadequate investigations into out-of-specification results, use of unqualified equipment, and incomplete laboratory and batch production records. The firm also failed to review electronically recorded quality data, indicating a lack of robust control over critical manufacturing and quality processes.

## Related Officers

- [ Drug Investigator](https://www.keypedia.com/people/samantha-j-bradley/ba45f64f-07a9-4933-833f-b9b339c57783)

Company: https://www.keypedia.com/companies/valens-molecules-private-limited/ba9bd53e-5e2c-4cc0-8379-b74d0a6b55b3

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd