# FDA 483 - Amphastar Nanjing Pharmaceuticals Inc - October 10, 2019

Source: https://www.keypedia.com/records/483/amphastar-nanjing-pharmaceuticals-inc/1b722d28-3603-4fae-a123-76b1bd4c8cb7

> FDA 483 for Amphastar Nanjing Pharmaceuticals Inc on October 10, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Amphastar Nanjing Pharmaceuticals Inc
- Inspection Date: 2019-10-10
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Amphastar Nanjing Pharmaceuticals, Inc. in Nanjing, China, revealed a deficiency in their annual visual inspection of retention samples. The firm's procedure and practice only included inspection of packaging, labeling, location, and quantity, but not the product itself. The company initiated corrective action during the inspection by updating their SOP to include product inspection.

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## Related Officers

- [Angela Glenn](https://www.keypedia.com/people/angela-glenn/5ba5e1e2-883b-42c4-aae0-3564820723e8)

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

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1