# FDA 483 - Guangdong Sunshine Pharmaceutical Co Ltd - April 18, 2025

Source: https://www.keypedia.com/records/483/guangdong-sunshine-pharmaceutical-co-ltd/bb694fc6-afaa-4a24-938e-978d244de6ad

> FDA 483 for Guangdong Sunshine Pharmaceutical Co Ltd on April 18, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Guangdong Sunshine Pharmaceutical Co Ltd
- Inspection Date: 2025-04-18
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Guangdong Sunshine Pharmaceutical Co. Ltd. was cited for significant deficiencies in its sterile drug product manufacturing, including inadequate aseptic process validation, poor operator practices, and deficient procedures for sanitization and environmental monitoring. The firm also failed to retest active pharmaceutical ingredients for critical attributes, did not consistently follow endotoxin testing procedures, and had shortcomings in quality control unit review of production records before batch release.

## Related Officers

- [Investigator](https://www.keypedia.com/people/patty-p-kaewussdangkul/1f0961fc-216e-4580-830a-56a76c0e7cea)

Company: https://www.keypedia.com/companies/guangdong-sunshine-pharmaceutical-co-ltd/de0eb7e6-f58e-4188-8355-29772f9ba9f8

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