# FDA 483 - Sucampo Pharma, LLC - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/sucampo-pharma-llc/822f9511-00e3-4c6c-8564-a66d8b7bfa69

> 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: International Compliance Team
- Summary: Sucampo Pharmaceuticals, LLC, an API manufacturer in Sanda, Japan, was cited for four observations during an FDA inspection. The inspection revealed issues including incomplete investigations into manufacturing deviations, unvalidated process parameters for drug substance dissolution, and inadequate investigation of product complaints. Additionally, the firm's gas chromatography instrument and software had a shared login and allowed data overwriting, raising data integrity concerns.

## 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/d54c326a-98b2-4b4d-89c9-f62ee9be3408)

## Related Officers

- [Brian D. Nicholson](https://www.globalkeysolutions.net/people/brian-d-nicholson/83ea13dd-6753-468a-a0ca-19e3ef4158dd)

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

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321