# FDA 483 - Hospira Australia Pty Ltd. - September 02, 2022

Source: https://www.globalkeysolutions.net/records/483/hospira-australia-pty-ltd/f2b81c3c-db02-4012-aef3-1534dff7c22d

> FDA 483 for Hospira Australia Pty Ltd. on September 02, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hospira Australia Pty Ltd.
- Inspection Date: 2022-09-02
- Product Type: drugs
- Office Name: FDA District Office — Silver Springs, Maryland
- Summary: Hospira Australia Pty Ltd, a sterile drug manufacturer in Mulgrave, Victoria, was cited for three observations during an FDA inspection. The firm failed to thoroughly investigate manufacturing discrepancies, did not consistently follow written procedures for equipment cleaning and maintenance, and exhibited inadequate aseptic processing techniques and sanitization practices in cleanroom environments. These issues indicate significant deficiencies in quality control and adherence to established procedures for sterile drug production.

## Related Documents

- [WARNING_LETTER - 2014-03-01](https://www.globalkeysolutions.net/records/warning_letter/hospira-australia-pty-ltd/3a8962ed-bdbd-4d71-901a-319261fb9686)

## Related Officers

- [Michele L. Glendenning](https://www.globalkeysolutions.net/people/michele-l-glendenning/a3c23a43-634c-4140-807b-c17fbc03bb00)

Company: https://www.globalkeysolutions.net/companies/hospira-australia-pty-ltd/43f04346-c63c-4c33-92ed-a42abafdd533

Office: https://www.globalkeysolutions.net/offices/fda-district-office-silver-springs-maryland/079bb75c-3759-4baa-baed-4159edd64552