# FDA 483 - Sionc Pharmaceuticals Private Limited - November 15, 2024

Source: https://www.keypedia.com/records/483/sionc-pharmaceuticals-private-limited/31ff0711-bde1-4998-b94e-95043ab65cd3

> FDA 483 for Sionc Pharmaceuticals Private Limited on November 15, 2024. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Sionc Pharmaceuticals Private Limited
- Inspection Date: 2024-11-15
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Sionc Pharmaceuticals Private Limited in Visakhapatnam, India, an Active Pharmaceutical Ingredient and intermediate manufacturer, revealed critical deficiencies in equipment maintenance and qualification. The firm failed to ensure that production equipment, including gaskets and filtration systems, was adequately maintained to prevent contamination of API and intermediates. These issues present a significant risk of chemical, microbiological, and particulate contamination in the manufactured products.

## Related Documents

- [483 - 2019-08-02](https://www.keypedia.com/records/483/sionc-pharmaceuticals-private-limited/46000116-5a9f-48e8-ae7b-f7ccd90f8410)

## Related Officers

- [Investigator](https://www.keypedia.com/people/marcellinus-d-dordunoo/a0e35c24-0cf5-4b11-95ba-1693fa3ecb3a)

Company: https://www.keypedia.com/companies/sionc-pharmaceuticals-private-limited/24c737f1-e449-4957-ad35-1990c5d68e2d

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8