# FDA 483 - Octapharma Produktionsgesellschaft Deutschland mbH - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/octapharma-produktionsgesellschaft-deutschland-mbh/9abcde7e-9994-46b8-891a-a968f0451c79

> FDA 483 for Octapharma Produktionsgesellschaft Deutschland mbH on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Octapharma Produktionsgesellschaft Deutschland mbH
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Octapharma Produktionsgesellschaft Deutschland mbH, a drug substance manufacturer in Springe, Germany, was cited for significant deficiencies in its quality systems. Observations included failures in batch release testing, inadequate deviation and CAPA procedures, insufficient environmental monitoring, and an inadequate cleaning validation program. These issues indicate a lack of robust controls over manufacturing processes and product quality.

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## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/yonggang-wang/5c7dd00f-f810-4f86-9c78-51ae7f4b8acd)
- [Mallory-Shelia](https://www.globalkeysolutions.net/people/mallory-shelia/90e53f09-e576-4f56-8158-c165ad86efb5)
- [investigator](https://www.globalkeysolutions.net/people/laura-fontan/b27b02a3-9ab1-49df-b2bc-ee936b69d76a)

Company: https://www.globalkeysolutions.net/companies/octapharma-produktionsgesellschaft-deutschland-mbh/6a1a14b1-f958-4ba6-b283-5c92ef67a783

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd