# FDA 483 - Sionc Pharmaceuticals Private Limited, Unit II - February 07, 2020

Source: https://www.keypedia.com/records/483/sionc-pharmaceuticals-private-limited-unit-ii/5a0103bb-7ffb-4715-b25d-0b8be9f53b43

> FDA 483 for Sionc Pharmaceuticals Private Limited, Unit II on February 07, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sionc Pharmaceuticals Private Limited, Unit II
- Inspection Date: 2020-02-07
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Sione Pharmaceuticals Private Limited in Parawada, India, was cited for significant deficiencies in its manufacturing processes. The inspection revealed a lack of written procedures for production and process controls, specifically concerning process validation for API, which included insufficient batch assessment and missing microbial content evaluation. Additionally, the firm failed to follow and adequately detail written procedures for equipment cleaning and maintenance, with multiple issues identified in cleaning validation studies.

## Related Officers

- [Bijoy Panicker](https://www.keypedia.com/people/bijoy-panicker/1c6ec57f-e02e-49b8-8b59-1853f3d2947a)

Company: https://www.keypedia.com/companies/sionc-pharmaceuticals-private-limited-unit-ii/b8c15cec-62ee-46e2-9e6d-afd955c22a5c

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