# FDA 483 - Ningbo Smart Pharmaceutical Co., Ltd. - October 29, 2010

Source: https://www.globalkeysolutions.net/records/483/ningbo-smart-pharmaceutical-co-ltd/73ff2ef2-affb-48a8-9aed-8876fd289f2d

> FDA 483 for Ningbo Smart Pharmaceutical Co., Ltd. on October 29, 2010. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ningbo Smart Pharmaceutical Co., Ltd.
- Inspection Date: 2010-10-29
- Product Type: drugs
- Office Name: Center for Veterinary Medicine
- Summary: Ningbo Smart Pharmaceutical Co Ltd, a drug substance manufacturer in Ningbo, P.R. China, was cited for multiple significant deficiencies during an FDA inspection. The observations primarily concern inadequate laboratory controls, including a lack of raw data for Certificates of Analysis, insufficient raw material testing, and unapproved qualification documents. These issues indicate a systemic failure in quality control and data integrity for API products shipped to the US market.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/kham-phommachanh/cc7e728e-d2a1-469d-be3a-4f5fdd43b2dc)

Company: https://www.globalkeysolutions.net/companies/ningbo-smart-pharmaceutical-co-ltd/f9ca71cb-747b-4ae7-b556-02fe170ea4a8

Office: https://www.globalkeysolutions.net/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4