# FDA 483 - Changzhou Sunlight Pharmaceutical Co., Ltd. - May 31, 2024

Source: https://www.keypedia.com/records/483/changzhou-sunlight-pharmaceutical-co-ltd/2031673a-3c88-4e41-b326-8113d7c4db60

> FDA 483 for Changzhou Sunlight Pharmaceutical Co., Ltd. on May 31, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Changzhou Sunlight Pharmaceutical Co., Ltd.
- Inspection Date: 2024-05-31
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Changzhou Sunlight Pharmaceutical Co., Ltd., an API manufacturer, was inspected by the FDA. The inspection revealed a significant issue where equipment used in the manufacturing of API intermediates was not operating within its appropriate range. This included discrepancies between set and actual parameters and the use of recording instruments with incorrect ranges, indicating potential quality control failures.

## Related Documents

- [483 - 2024-05-31](https://www.keypedia.com/records/483/changzhou-sunlight-pharmaceutical-co-ltd/e24db508-88f6-46bc-8cd4-5372ba7e0190)

## Related Officers

- [Robin P. Mathew](https://www.keypedia.com/people/robin-p-mathew/35f4a085-58b8-4208-a648-ef2d533e1ece)
- [Kshitij A. Patkar](https://www.keypedia.com/people/kshitij-a-patkar/feaedcad-cb5c-4179-995e-d96af0bc9278)

Company: https://www.keypedia.com/companies/changzhou-sunlight-pharmaceutical-co-ltd/8dec389f-df74-4d58-8aa0-61eba8abd2eb

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