# FDA 483 - Samchundang Pharm Co., Ltd. - October 25, 2019

Source: https://www.keypedia.com/records/483/samchundang-pharm-co-ltd/5dba6b94-88de-44dd-9f9e-6fa30bdf9767

> FDA 483 for Samchundang Pharm Co., Ltd. on October 25, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Samchundang Pharm Co., Ltd.
- Inspection Date: 2019-10-25
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: This 483 report for Samchundang Pharm Co., Ltd. details significant deficiencies across multiple quality system areas, including quality control unit responsibilities, personnel training, complaint handling, data integrity, aseptic processing, environmental monitoring, and laboratory controls. The observations highlight a lack of written procedures, inadequate adherence to established SOPs, and insufficient validation and testing practices for US-marketed products. These issues collectively indicate a systemic failure to ensure product quality, purity, strength, and compliance with GMP regulations.

## Related Documents

- [WARNING_LETTER - 2019-10-25](https://www.keypedia.com/records/warning_letter/samchundang-pharm-co-ltd/feb7da80-5052-406c-8658-c15e62f36fba)

## Related Officers

- [Philip F. Istafanos](https://www.keypedia.com/people/philip-f-istafanos/c2fcfe52-1070-4551-bffc-f8bcfad5b30b)
- [Yvins Dezan](https://www.keypedia.com/people/yvins-dezan/e9fd12e6-c090-4eb6-bc78-8b80e8a90946)

Company: https://www.keypedia.com/companies/samchundang-pharm-co-ltd/953048a3-14c3-475b-bebc-f43b8755905e

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