# FDA 483 - Aspen Oss B.V. - September 09, 2019

Source: https://www.globalkeysolutions.net/records/483/aspen-oss-bv/9629ede7-070e-43e4-9ec8-f920c1df2dcd

> FDA 483 for Aspen Oss B.V. on September 09, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aspen Oss B.V.
- Inspection Date: 2019-09-09
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Aspen Oss B.V., a drug manufacturer in Oss, Noord-Brabant NL, was cited for significant deficiencies in its quality control and manufacturing processes. Observations included a lack of validated control procedures leading to out-of-specification drug product test results and non-representative sampling practices. The firm also failed to adequately investigate unexplained discrepancies and OOS microbial counts, and did not document the examination and reconciliation of packaging and labeling materials in batch records.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/guerlain-ulysse/aeef6f71-43b1-4116-b563-8bb3f2966d6a)

Company: https://www.globalkeysolutions.net/companies/aspen-oss-bv/923bb273-2fc1-4fe7-9ac1-7bc87d0076df

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