# FDA 483 - Zhejiang Poly Pharm. Co., Ltd - November 08, 2024

Source: https://www.globalkeysolutions.net/records/483/zhejiang-poly-pharm-co-ltd/86640f55-e86a-43c3-a38a-48b971745ed9

> FDA 483 for Zhejiang Poly Pharm. Co., Ltd on November 08, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zhejiang Poly Pharm. Co., Ltd
- Inspection Date: 2024-11-08
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Zhejiang Poly Pharm. Co., Ltd, a drug product manufacturer in Linping, China, was cited for significant deficiencies during an FDA inspection. Observations included a lack of written procedures for production and process controls, failure to validate processes for US-bound products, and inadequate equipment cleaning and data integrity controls. These issues indicate a serious lack of adherence to cGMP regulations.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/zhejiang-poly-pharm-co-ltd/9831a921-6b44-49a1-b472-a3f475bc446b

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