# FDA 483 - Wild Child Laboratories Pty Ltd. - May 31, 2019

Source: https://www.globalkeysolutions.net/records/483/wild-child-laboratories-pty-ltd/cced06ee-afd7-4e1f-99b3-b6d843f1faa1

> FDA 483 for Wild Child Laboratories Pty Ltd. on May 31, 2019. 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: 2019-05-31
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Wild Child WA Pty Ltd., an OTC Drug Product Manufacturer in Malaga, Australia, was inspected by the FDA from May 27-31, 2019. The inspection revealed significant deficiencies across its quality control, laboratory, production, and material systems. Key issues include a failure to investigate deviations, inadequate product testing, lack of process validation, and insufficient raw material identification, raising concerns about the quality and purity of US-marketed products.

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## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/unnee-ranjan/43f1d07e-4079-4d33-88a9-baf6a5df932c)

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