# FDA 483 - Sucampo Pharma, LLC - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/sucampo-pharma-llc/d54c326a-98b2-4b4d-89c9-f62ee9be3408

> FDA 483 for Sucampo Pharma, LLC on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sucampo Pharma, LLC
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Sucampo Pharma, LLC in Sanda, Hyogo, Japan, identified an inadequacy in the testing procedures for establishing the purity of in-house primary reference standards. The firm's re-qualification process for API reference standards was found to be insufficient, as it relied on initial qualification test results for certain parameters rather than current testing. This observation highlights a concern regarding the quality control of critical reference materials used in manufacturing.

## Related Documents

- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/sucampo-pharma-llc/d1bb6aaa-42c6-4155-a7e8-08fe354c672c)
- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/sucampo-pharma-llc/822f9511-00e3-4c6c-8564-a66d8b7bfa69)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/gavin-t-cua/6f498dd6-2c4b-42e9-8ddc-3c2a7c97afef)

Company: https://www.globalkeysolutions.net/companies/sucampo-pharma-llc/5a5bffc7-663f-47ab-8ccf-2078e2f49f60

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