# Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (FDF Site) – FDA 483, May 15, 2026

Source: https://www.keypedia.com/records/483/nanjing-king-friend-biochemical-pharmaceutical-co-ltd-fdf-site/b41eca71-424d-4301-9dec-63dd921d726a

> FDA 483 for Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (FDF Site) on May 15, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (FDF Site)
- Inspection Date: 2026-05-15
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: An FDA inspection of Nanjing King-Friend Biochemical Pharmaceutical Co. Ltd., an API and Drug Manufacturer in Nanjing, China, revealed significant deficiencies across multiple areas. Observations included inadequate cleaning programs and validation for manufacturing equipment, insufficient investigations into out-of-specification (OOS) results, and failures in laboratory controls regarding scientifically sound test procedures and stability sample handling. These issues indicate a lack of robust quality control and manufacturing practices that could impact product safety and purity.

## Related Documents

- 483 - 2025-12-15 — date: December 15, 2025
- [483 - 2018-04-03](https://www.keypedia.com/records/483/nanjing-king-friend-biochemical-pharmaceutical-co-ltd-fdf-site/5067c57b-7e67-4f78-87ab-a42f4d4b0b5c) — date: April 3, 2018

## Related Officers

- [Dipesh K. Shah](https://www.keypedia.com/people/dipesh-k-shah/d4df4040-13d1-477b-8c21-4c8e5b3fc5b9)

Company: https://www.keypedia.com/companies/nanjing-king-friend-biochemical-pharmaceutical-co-ltd-fdf-site/ffbee76e-a9d5-417d-bcf6-0bc5f1d70498

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3