# FDA 483 - PharmaEssentia Corporation, Taichung Plant - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/pharmaessentia-corporation-taichung-plant/9dc88250-9156-45aa-a21a-70c437863018

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

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## Details

- Record Type: 483
- Company Name: PharmaEssentia Corporation, Taichung Plant
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of PharmaEssentia Corporation, Taichung Plant, a drug substance manufacturer, revealed two significant observations. The firm failed to adequately investigate complaints of lack of therapeutic efficacy, neglecting to review manufacturing records, analytical data, or retention samples. Additionally, the bacterial endotoxin testing method was found to be inadequate due to issues with sample container validation and the use of uncalibrated equipment.

## Related Documents

- [483 - 2023-09-21](https://www.globalkeysolutions.net/records/483/pharmaessentia-corporation-taichung-plant/a3ba557a-1490-40a0-a21c-076154f9573e)

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/jeffrey-p-raimondi/7576ca4e-d9e8-4015-9ae6-9498e76058d3)

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

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