# FDA 483 - Zenara Pharma Pvt Ltd - May 21, 2024

Source: https://www.keypedia.com/records/483/zenara-pharma-pvt-ltd/97ac8e79-7c19-43b9-845c-7adf3824b341

> FDA 483 for Zenara Pharma Pvt Ltd on May 21, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zenara Pharma Pvt Ltd
- Inspection Date: 2024-05-21
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: Zenara Pharma Pvt Ltd, a drug manufacturer in Hyderabad, India, was cited for significant deficiencies in its quality systems. Observations included inadequate production and process controls, poorly designed manufacturing equipment leading to yield issues, and a lack of proficiency in data integrity audit trail reviews. The inspection also noted insufficient investigation into out-of-specification dissolution results.

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## Related Officers

- [Teresa I. Navas](https://www.keypedia.com/people/teresa-i-navas/43f747c0-18c2-4630-bab9-936204aa93aa)

Company: https://www.keypedia.com/companies/zenara-pharma-pvt-ltd/6a2ceafb-9847-4a53-88dc-ef0b522b04a1

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3