# FDA 483 - Nanhai Beisha Pharmaceutical Co., Ltd. - September 19, 2025

Source: https://www.keypedia.com/records/483/nanhai-beisha-pharmaceutical-co-ltd/711fde44-e52a-4976-8a30-0e76c5acf484

> FDA 483 for Nanhai Beisha Pharmaceutical Co., Ltd. on September 19, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nanhai Beisha Pharmaceutical Co., Ltd.
- Inspection Date: 2025-09-19
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Nanhai Beisha Pharmaceutical Co., Ltd. in Nanhai, China, revealed four significant observations concerning its API manufacturing operations. The firm failed to maintain accurate and contemporaneous documentation, control written records, and establish adequate cleaning procedures for equipment. Additionally, raw materials were not stored under appropriate temperature conditions, indicating a lack of adherence to GMP requirements.

## Related Officers

- [Evan Tong](https://www.keypedia.com/people/evan-tong/2cd81562-886c-4672-9522-a07fb1b33ef2)
- [Pharmacist | Consumer Safety Officer](https://www.keypedia.com/people/victoria-spivak/b43d066f-35c1-4d83-9d38-3ba64d77cf31)

Company: https://www.keypedia.com/companies/nanhai-beisha-pharmaceutical-co-ltd/26bc6ed1-b4ef-4c70-9983-30dbb8e592dd

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