# FDA 483 - Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (FDF Site) - April 03, 2018

Source: https://www.keypedia.com/records/483/nanjing-king-friend-biochemical-pharmaceutical-co-ltd-fdf-site/5067c57b-7e67-4f78-87ab-a42f4d4b0b5c

> FDA 483 for Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (FDF Site) on April 03, 2018. 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: 2018-04-03
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. in Nanjing, China, revealed significant deficiencies in their manufacturing processes for sterile drug products. Observations included inadequate procedures for preventing microbiological contamination, deficiencies in environmental monitoring within aseptic processing areas, and a lack of validated control procedures for manufacturing processes. Additionally, the firm failed to adequately qualify suppliers for containers and closures by not verifying test results.

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## Related Officers

- [Darren S Brown, Investigator](https://www.keypedia.com/people/darren-s-brown-investigator/183d4712-6223-4f23-9f17-e4678e0e3c5d)
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- [Rose Xu, Reviewer](https://www.keypedia.com/people/rose-xu-reviewer/55420292-e5f3-400f-9da9-6dbf2d9a1d0a)

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/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd