# FDA 483 - PharmaEssentia Corporation, Taichung Plant - September 21, 2023

Source: https://www.keypedia.com/records/483/pharmaessentia-corporation-taichung-plant/a3ba557a-1490-40a0-a21c-076154f9573e

> FDA 483 for PharmaEssentia Corporation, Taichung Plant on September 21, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PharmaEssentia Corporation, Taichung Plant
- Inspection Date: 2023-09-21
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of PharmaEssentia Corporation's Drug Product and PEG Facility in Taichung, Taiwan, revealed significant deficiencies across multiple areas of sterile drug product manufacturing. The firm's visual inspection procedures, environmental controls, sterilization validation, and process monitoring were found to be inadequate. Additionally, issues with deviation investigations, data integrity, and incoming material release practices were identified, indicating a lack of robust quality control and assurance.

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/pharmaessentia-corporation-taichung-plant/9dc88250-9156-45aa-a21a-70c437863018)

## Related Officers

- [Hamet Touré, PharmD MPH, Regulatory Officer](https://www.keypedia.com/people/hamet-toure-pharmd-mph-regulatory-officer/90e0a7c5-7fff-4dfe-a893-7d7cad038a15)
- [Madushini Dharmasena, Ph.D., Senior Pharmaceutical Quality Assessor](https://www.keypedia.com/people/madushini-dharmasena-phd-senior-pharmaceutical-quality-assessor/c2889164-8138-4129-a531-fdabde8d1b4b)

Company: https://www.keypedia.com/companies/pharmaessentia-corporation-taichung-plant/97fafa0d-9006-45e0-a880-334c4e58248a

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