# FDA 483 - Amphastar Nanjing Pharmaceuticals Inc - September 19, 2025

Source: https://www.keypedia.com/records/483/amphastar-nanjing-pharmaceuticals-inc/1ffd1e19-78e3-4e8b-938b-dfab3199a0e1

> FDA 483 for Amphastar Nanjing Pharmaceuticals Inc on September 19, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Amphastar Nanjing Pharmaceuticals Inc
- Inspection Date: 2025-09-19
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Amphastar Nanjing Pharmaceuticals, Inc. in Nanjing, China, was inspected for drug substance manufacturing and received a Form 483 with seven observations. The inspection revealed significant deficiencies across facility design, quality unit oversight, material management, manufacturing controls, laboratory procedures, documentation, and risk assessment, indicating a broad lack of cGMP compliance. These issues collectively pose a high risk of microbial contamination and product quality impact.

## Related Documents

- [483 - 2019-10-10](https://www.keypedia.com/records/483/amphastar-nanjing-pharmaceuticals-inc/1b722d28-3603-4fae-a123-76b1bd4c8cb7)

## Related Officers

- [Tamanna Azam](https://www.keypedia.com/people/tamanna-azam/0fe21912-a62e-4606-9451-e0777090bfee)
- [Xiaoshi Wang](https://www.keypedia.com/people/xiaoshi-wang/8249ff14-dec6-4ffd-9893-bdf8ba6af7ce)
- [Duan Singh](https://www.keypedia.com/people/duan-singh/8f6e0c84-e1d4-4ce6-8b91-9f2e3f641155)
- [Doan N. Singh](https://www.keypedia.com/people/doan-n-singh/e52cfbca-5710-4765-8c5e-d534946b648d)

Company: https://www.keypedia.com/companies/amphastar-nanjing-pharmaceuticals-inc/ad29710e-4137-4608-933e-8292394dcbc7

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