# FDA 483 - Valary Lab Private Limited - August 22, 2022

Source: https://www.globalkeysolutions.net/records/483/valary-lab-private-limited/8b127dff-e46d-4e39-a530-751dfdce5182

> FDA 483 for Valary Lab Private Limited on August 22, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Valary Lab Private Limited
- Inspection Date: 2022-08-22
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Valary Lab Pvt Ltd, an API manufacturer, received a Form 483 citing two observations related to manufacturing controls. The firm failed to document deviations and conduct appropriate investigations in manufacturing batch records. Additionally, manufacturing batch and control records were found to contain incomplete information regarding production and testing.

## Related Officers

- [Consumer Safety Officer (Drug Specialist)](https://www.globalkeysolutions.net/people/alan-p-kurtzberg/36ee316e-6d19-44b2-a131-fc254ada4f41)

Company: https://www.globalkeysolutions.net/companies/valary-lab-private-limited/b99d8a02-fbf0-4b9f-8e8f-2a1097725ff7

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