# FDA 483 - Orient Pharma Co., Ltd. Yunlin Plant - September 07, 2022

Source: https://www.globalkeysolutions.net/records/483/orient-pharma-co-ltd-yunlin-plant/9688c9de-0bad-4d7c-90fe-6d7b36bea0d6

> FDA 483 for Orient Pharma Co., Ltd. Yunlin Plant on September 07, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Orient Pharma Co., Ltd. Yunlin Plant
- Inspection Date: 2022-09-07
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Orient Pharma Co., Ltd in Yunlin County, Taiwan, revealed two significant observations. The firm's batch production and control records were found to be deficient, lacking complete documentation for manufacturing steps. Additionally, the facility's stability room was not maintained in a clean and sanitary condition, with dirt, water drips, and stains observed.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/kham-phommachanh/cc7e728e-d2a1-469d-be3a-4f5fdd43b2dc)

Company: https://www.globalkeysolutions.net/companies/orient-pharma-co-ltd-yunlin-plant/c8cecdbc-ad8f-4820-87c2-1c2d47b95e8d

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