# FDA 483 - Zenara Pharma Pvt Ltd - December 16, 2019

Source: https://www.globalkeysolutions.net/records/483/zenara-pharma-pvt-ltd/9a31d9be-f1f0-4a29-be0c-1e96977476d4

> FDA 483 for Zenara Pharma Pvt Ltd on December 16, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zenara Pharma Pvt Ltd
- Inspection Date: 2019-12-16
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Zenara Pharma Pvt Ltd in Hyderabad, India, was issued a Form 483 with nine observations following an FDA inspection. The firm demonstrated significant deficiencies across its quality control unit, laboratory procedures, production records, equipment maintenance, and personnel training. Key issues include inadequate investigations into out-of-specification results, insufficient process controls for scale-up batches, and incomplete master production records, indicating a lack of adherence to current Good Manufacturing Practices.

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## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/anitha-p-govada/07f94777-660b-4b81-b63c-54f3b4a8635e)
- [Quality System Specialist](https://www.globalkeysolutions.net/people/jose-e-melendez/75bd6083-14a4-4bd2-a0e5-9946d4dd37e1)

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

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