# FDA 483 - Keshava Organics Private Ltd. - January 13, 2023

Source: https://www.globalkeysolutions.net/records/483/keshava-organics-private-ltd/2d64611a-9188-481e-ba3d-aeb7e534ce08

> FDA 483 for Keshava Organics Private Ltd. on January 13, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Keshava Organics Private Ltd.
- Inspection Date: 2023-01-13
- Product Type: drugs
- Office Name: Office of Pharmaceutical Quality Operations
- Summary: Fermenta Organics Private Ltd in Tarapur, India, an API manufacturer, received a Form 483 with two observations. The inspection revealed a lack of written procedures for production and process controls, including missing manufacturing process validation and stability evaluations for recovered drug substance. Additionally, the firm failed to perform impact assessments for stability samples stored in a malfunctioning stability chamber.

## Related Officers

- [Bijoy Panicker](https://www.globalkeysolutions.net/people/bijoy-panicker/1c6ec57f-e02e-49b8-8b59-1853f3d2947a)
- [issuing_officer](https://www.globalkeysolutions.net/people/gam-s-zamil/75bc04d4-6013-43b5-8200-8b513c814a7c)

Company: https://www.globalkeysolutions.net/companies/keshava-organics-private-ltd/0c7f92d6-f643-4c00-881a-9c4ef783fd37

Office: https://www.globalkeysolutions.net/offices/office-of-pharmaceutical-quality-operations/6b0153a9-c1d1-46a5-8b10-836d2ae44ffe