# FDA 483 - Adimmune Corporation - Unknown Date

Source: https://www.keypedia.com/records/483/adimmune-corporation/0b25b24a-d8ed-463d-b0f8-d1ba52c676e3

> FDA 483 for Adimmune Corporation on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Adimmune Corporation
- Product Type: biologics
- Office Name: International Compliance Team
- Summary: An FDA inspection of Adimmune Corporation, a biological drug manufacturer in Taichung City, Taiwan, identified two significant observations. The firm's batch records and procedures were found to be inadequate in documenting production instructions and data, including alarm logs and equipment identification. Additionally, automatic equipment used for visual inspection of vaccine products lacked adequate control over its parameters, leading to confusion due to duplicate electronic recipes with differing rejection values.

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/adimmune-corporation/bfd236ea-c0a3-4dc8-a4eb-432bc41f4b19)

## Related Officers

- [Scott T. Ballard](https://www.keypedia.com/people/scott-t-ballard/09b2ae9a-3b30-45bd-bac1-437365e938da)
- [Investigator](https://www.keypedia.com/people/thai-d-truong/7395c128-0adb-44a1-8831-64673c98e93d)

Company: https://www.keypedia.com/companies/adimmune-corporation/ef2a0feb-a3b7-45e4-91a6-15d344543027

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321