# FDA 483 - Aspen SA Sterile Operations (Pty) Ltd. - September 17, 2024

Source: https://www.keypedia.com/records/483/aspen-sa-sterile-operations-pty-ltd/46e4cb00-f31a-4922-bbf7-1d4c606720d4

> FDA 483 for Aspen SA Sterile Operations (Pty) Ltd. on September 17, 2024. 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: 2024-09-17
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An inspection of Aspen SA Sterile Operations (Pty) Ltd. revealed critical deficiencies in aseptic processing, quality control, and data integrity for sterile drug products. The firm failed to establish and follow procedures to prevent microbiological contamination, adequately validate aseptic processes, and thoroughly investigate numerous stability failures, out-of-specification results, and customer complaints. These issues indicate a severe lack of control over manufacturing processes and product quality, posing significant risks to product sterility and efficacy.

## Related Documents

- [483 - 2018-12-04](https://www.keypedia.com/records/483/aspen-sa-sterile-operations-pty-ltd/e74bd9a0-bd9d-4483-bb71-66c2f704eee3)

## Related Officers

- [Josh Renzo N. Ramilo](https://www.keypedia.com/people/josh-renzo-n-ramilo/5b0850ba-e22a-42fc-9310-2beeb921f8f6)
- [Research Specialist II](https://www.keypedia.com/people/justin-a-boyd/796c9c9d-02db-486c-bdca-cc259066a0e2)

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-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8