# FDA 483 - Tismor Health and Wellness Pty Limited - May 24, 2019

Source: https://www.globalkeysolutions.net/records/483/tismor-health-and-wellness-pty-limited/a382185d-0813-48ec-b4a3-199bfcca0860

> FDA 483 for Tismor Health and Wellness Pty Limited on May 24, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tismor Health and Wellness Pty Limited
- Inspection Date: 2019-05-24
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Tismor Health and Wellness Pty Limited, an OTC drug product manufacturer in Kingsgrove, Australia, revealed significant deficiencies across its quality system. The firm failed to adhere to quality control unit procedures for batch release, exhibited poor laboratory control practices including data integrity issues, and lacked appropriate controls over computer systems and manufacturing processes. These findings indicate a lack of assurance in product quality and data reliability for products destined for the U.S. market.

## Related Documents

- [WARNING_LETTER - 2019-05-24](https://www.globalkeysolutions.net/records/warning_letter/tismor-health-and-wellness-pty-limited/010166f0-b865-4b06-886a-6ed8c43a8fc8)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/tismor-health-and-wellness-pty-limited/5594bb7c-9fd6-4dea-b948-5b80b117763b

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