# FDA 483 - Adimmune Corporation - Unknown Date

Source: https://www.keypedia.com/records/483/adimmune-corporation/bfd236ea-c0a3-4dc8-a4eb-432bc41f4b19

> 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: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Adimmune Corporation, a vaccine manufacturer in Taichung City, Taiwan, revealed significant deficiencies across its operations. The firm was cited for inadequate media simulation and media fill studies, insufficient quality control review of batch records, and incomplete validation of sterilization processes. Other critical issues included improper storage of drug substance, inadequate Quality Unit procedures, incomplete process and equipment validations, and deficiencies in environmental monitoring and testing instructions.

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/adimmune-corporation/0b25b24a-d8ed-463d-b0f8-d1ba52c676e3)

## Related Officers

- [Cynthia Jim](https://www.keypedia.com/people/cynthia-jim/e0f1c8a7-d787-442a-911c-61e37cd806a6)

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

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd