# FDA WARNING_LETTER - Commonwealth Serum Laboratories (CSL), Ltd. - March 31, 2011

Source: https://www.keypedia.com/records/warning_letter/commonwealth-serum-laboratories-csl-ltd/de5e3f1b-311a-4fb2-b617-8bce783ab9e4

> FDA WARNING_LETTER for Commonwealth Serum Laboratories (CSL), Ltd. on March 31, 2011. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Commonwealth Serum Laboratories (CSL), Ltd.
- Inspection Date: 2011-03-31
- Product Type: Devices
- Office Name: Department of Health and Human Services
- Summary: The FDA issued a Warning Letter to CSL Biotherapies following an inspection from March 21-31, 2011, at their Parkville, Australia facility. The inspection documented deviations from current Good Manufacturing Practice (CGMP) requirements for licensed biological vaccine Afluria and monovalent influenza bulks, violating Sections 501(a)(2)(B) of the FD&C Act, 351(a) of the PHS Act, and 21 CFR Parts 210, 211, and 600-680.

Significant deviations included:
1.  **Inadequate Investigations:** Failure to thoroughly investigate unexplained discrepancies or batch failures. Examples cited were an insufficient investigation into Afluria adverse events (fever/convulsions in children), lacking documentation, limited manufacturing process analysis, and no testing for (b)(4) content differences. Also, an inadequate investigation into dark particles in thimerosal-containing multi-dose vials, focusing only on multi-dose vials without sufficient rationale.
2.  **Production and Process Control Deficiencies:** Failure to establish and follow written controls, such as not determining optimal splitting conditions for new virus strains (e.g., A/Victoria/210/2009) before production, and not reviewing Haemagglutinin Antigen (HA) presence in (b)(4) seasonally.
3.  **Inadequate Failure

## Related Officers

- [Director -  - Ex-FDA](https://www.keypedia.com/people/mary-a-malarkey/11b99e21-5f75-4b61-83bc-d140e35e4dae)
- [Clare Barker](https://www.keypedia.com/people/clare-barker/cd257a79-6a7f-45fc-950c-41b6f9d96ba8)
- [Paul R. Hartmann](https://www.keypedia.com/people/paul-r-hartmann/d559ed83-36b7-4564-9b90-dc0f3fcbfdc3)

Company: https://www.keypedia.com/companies/commonwealth-serum-laboratories-csl-ltd/2e939ebd-361f-4c54-8c49-c6a9f6981a76

Office: https://www.keypedia.com/offices/department-of-health-and-human-services/cecfcda4-4afa-4a1f-a7b7-a020b79f9861