# FDA 483 - Tianjin Central Pharmaceutical Co., Ltd. - December 17, 2021

Source: https://www.globalkeysolutions.net/records/483/tianjin-central-pharmaceutical-co-ltd/fdebcef8-cda0-4507-b373-72c92c48a34c

> FDA 483 for Tianjin Central Pharmaceutical Co., Ltd. on December 17, 2021. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tianjin Central Pharmaceutical Co., Ltd.
- Inspection Date: 2021-12-17
- Product Type: other
- Office Name: Center for Veterinary Medicine
- Summary: Tianjin Central Pharmaceutical Co., Ltd. received a Form 483 for significant deficiencies in its dietary supplement manufacturing processes. The inspection revealed a lack of process validation for sterilization steps, inadequate record-keeping for critical parameters, and unsanitary conditions with unidentifiable material found on supposedly cleaned equipment surfaces. These issues indicate a failure to ensure the quality and safety of dietary supplements, including those exported to the USA.

## Related Officers

- [Edward P. Potter](https://www.globalkeysolutions.net/people/edward-p-potter/751ea63e-4884-4fa7-a7f6-f7bfde1a0863)

Company: https://www.globalkeysolutions.net/companies/tianjin-central-pharmaceutical-co-ltd/26c20286-f5d6-4612-8e6f-d7392fd08b82

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