# FDA 483 - Second Pharma Co., Ltd. - August 30, 2024

Source: https://www.globalkeysolutions.net/records/483/second-pharma-co-ltd/7360edfa-0c77-4ebb-b3f7-e1cbceabab56

> FDA 483 for Second Pharma Co., Ltd. on August 30, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Second Pharma Co., Ltd.
- Inspection Date: 2024-08-30
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Second Pharma Co., Ltd., an API manufacturer, revealed significant deficiencies in quality control. The firm failed to adequately monitor water for objectionable organisms, establish proper cleaning validation for shared manufacturing equipment, and thoroughly investigate out-of-specification results, including extending investigations to potentially affected batches. These issues indicate a lack of robust quality systems impacting product purity and safety.

Company: https://www.globalkeysolutions.net/companies/second-pharma-co-ltd/8edb6004-77bb-46b8-9347-b7df0bdb670f

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