# FDA 483 - Sionc Pharmaceuticals Private Limited - August 02, 2019

Source: https://www.keypedia.com/records/483/sionc-pharmaceuticals-private-limited/46000116-5a9f-48e8-ae7b-f7ccd90f8410

> FDA 483 for Sionc Pharmaceuticals Private Limited on August 02, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sionc Pharmaceuticals Private Limited
- Inspection Date: 2019-08-02
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Sync Pharmaceuticals Pvt. Ltd., an API manufacturer in Parawada, India, revealed significant deficiencies in their quality control unit and cleaning process validation. Inspectors found inadequate controls over electronic data, including unpassworded hard drives and shared computer logins, raising concerns about data integrity. Additionally, the firm failed to adequately document cleaning process validation, with inconsistent surface area calculations lacking justification.

## Related Documents

- [483 - 2024-11-15](https://www.keypedia.com/records/483/sionc-pharmaceuticals-private-limited/31ff0711-bde1-4998-b94e-95043ab65cd3)

## Related Officers

- [Dipesh K. Shah](https://www.keypedia.com/people/dipesh-k-shah/d4df4040-13d1-477b-8c21-4c8e5b3fc5b9)

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

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