# FDA 483 - Biomedix Wai - October 31, 2019

Source: https://www.keypedia.com/records/483/biomedix-wai/dc95774c-769a-4429-8667-affcdfbe5f4c

> FDA 483 for Biomedix Wai on October 31, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biomedix Wai
- Inspection Date: 2019-10-31
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Biocodix WAI received an FDA Form 483 citing multiple deficiencies primarily related to inadequate process validation, quality system procedures, and equipment controls. Key issues include insufficient validation of sealing processes, lack of monitoring for validated parameters, inadequate handling of non-conforming products, and deficiencies in supplier and change control. The report highlights repeat observations from previous inspections, indicating persistent quality system failures.

## Related Documents

- [WARNING_LETTER - 2019-10-31](https://www.keypedia.com/records/warning_letter/biomedix-wai/f35cb5bf-0dd2-4b7c-b939-d5e8bc85ffb4)

## Related Officers

- [ Investigator ](https://www.keypedia.com/people/joseph-r-strelnik/1fb7d50e-abf2-45ef-85a8-71c61b33e42d)

Company: https://www.keypedia.com/companies/biomedix-wai/35aa0e7f-c8eb-40a8-9b5b-5b57fa435abf

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0