# FDA 483 - Chongqing Biocare Pharmaceutical Ltd. - September 22, 2023

Source: https://www.keypedia.com/records/483/chongqing-biocare-pharmaceutical-ltd/e3f790d4-9ab2-4a9c-a6d4-6c9451d79122

> FDA 483 for Chongqing Biocare Pharmaceutical Ltd. on September 22, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Chongqing Biocare Pharmaceutical Ltd.
- Inspection Date: 2023-09-22
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Chongqing Biocare Pharmaceutical Ltd. in Chongqing, China, an API manufacturer, revealed issues with facility and equipment maintenance. Observations included improperly repaired and maintained surfaces in a clean area, loose insulation above manufacturing equipment, and a static electricity discharge device that had come loose from a warehouse wall. These conditions indicate a lack of proper control over the manufacturing environment and equipment.

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Company: https://www.keypedia.com/companies/chongqing-biocare-pharmaceutical-ltd/43b87a2f-392a-4858-ae70-9515bddeeadd

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