# FDA 483 - Aspen SA Sterile Operations (Pty) Ltd. - December 04, 2018

Source: https://www.keypedia.com/records/483/aspen-sa-sterile-operations-pty-ltd/e74bd9a0-bd9d-4483-bb71-66c2f704eee3

> FDA 483 for Aspen SA Sterile Operations (Pty) Ltd. on December 04, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aspen SA Sterile Operations (Pty) Ltd.
- Inspection Date: 2018-12-04
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Aspen SVP Pty Ltd. in Port Elizabeth, South Africa, was cited for significant deficiencies in its manufacturing processes for sterile drug products. The inspection revealed widespread issues with aseptic techniques, quality control unit oversight, laboratory controls, and facility maintenance, indicating a systemic failure to prevent contamination and ensure product quality.

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## Related Officers

- [Cheryl A. Clausen](https://www.keypedia.com/people/cheryl-a-clausen/2306b2bc-8f01-4f77-ba2d-1a3186d6f6fc)
- [Investigator](https://www.keypedia.com/people/michael-r-shanks/dd24952b-4309-451e-afe8-f68892cd7bac)

Company: https://www.keypedia.com/companies/aspen-sa-sterile-operations-pty-ltd/b4918ce4-3b81-4fb7-bd04-2e1110728456

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