# FDA 483 - Hangzhou ApexTide Biomedical Technology Co., Ltd. - November 01, 2024

Source: https://www.keypedia.com/records/483/hangzhou-apextide-biomedical-technology-co-ltd/dfe41cbb-6066-4438-878c-f19ec1361dc5

> FDA 483 for Hangzhou ApexTide Biomedical Technology Co., Ltd. on November 01, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hangzhou ApexTide Biomedical Technology Co., Ltd.
- Inspection Date: 2024-11-01
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Hangzhou ApexTide Biomedical Technology Co., Ltd. in Hangzhou, China, revealed significant deficiencies in the manufacturing and quality control of Active Pharmaceutical Ingredients (API). The firm failed to complete process validation, adequately qualify manufacturing areas and equipment, and ensure proper testing of starting materials and water used in production. These issues raise concerns about the quality, purity, and stability of API shipped to the US market.

## Related Officers

- [Nibin Varghese](https://www.keypedia.com/people/nibin-varghese/43e17f63-2c1f-4d46-b26f-dc8ac8885438)

Company: https://www.keypedia.com/companies/hangzhou-apextide-biomedical-technology-co-ltd/0bdf8f05-4699-4044-9bc2-13608fdf3953

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