# FDA 483 - Wild Child Laboratories Pty Ltd. - June 21, 2024

Source: https://www.globalkeysolutions.net/records/483/wild-child-laboratories-pty-ltd/e8092dd1-7874-455e-b535-e067aa4aea06

> FDA 483 for Wild Child Laboratories Pty Ltd. on June 21, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Wild Child Laboratories Pty Ltd.
- Inspection Date: 2024-06-21
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Wild Child Laboratories Pty Ltd. in Osborne Park, Australia, an OTC drug manufacturer, was cited for significant deficiencies in its quality control and manufacturing processes. The inspection revealed a lack of validated manufacturing processes, inadequate stability testing, and failures in investigating out-of-specification results and customer complaints. These issues indicate a systemic breakdown in ensuring drug product quality, identity, strength, and purity.

## Related Documents

- [483 - 2019-05-31](https://www.globalkeysolutions.net/records/483/wild-child-laboratories-pty-ltd/cced06ee-afd7-4e1f-99b3-b6d843f1faa1)

## Related Officers

- [Consumer Safety Officer ](https://www.globalkeysolutions.net/people/anastasia-m-shields/a22b8d52-e3f9-4e61-aa3f-6f03ff2f59df)

Company: https://www.globalkeysolutions.net/companies/wild-child-laboratories-pty-ltd/b52942c7-79c3-41bd-ab62-a8b3ddd6fb6b

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