# FDA 483 - Broekman Instituut B.V. - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/broekman-instituut-bv/08611032-4be7-4153-8f30-8577121f3df8

> FDA 483 for Broekman Instituut B.V. on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Broekman Instituut B.V.
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Broekman Institute in Someren, Noord-brabant received a Form 483 with six observations primarily related to quality control, documentation, and environmental monitoring. Issues included a lack of deviation reports for bioburden exceedances, insufficient validation data for storage bags, and untimely closure of non-conformance reports and CAPAs. The findings indicate significant deficiencies in the firm's quality management system and control over manufacturing processes.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/omotunde-osunsanmi/41c6ef66-1d5c-4940-8b1f-628da20cde34)

Company: https://www.globalkeysolutions.net/companies/broekman-instituut-bv/9283f823-0b3f-4a21-afe2-1357240d404f

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