# FDA 483 - Samsung Biologics Co., Ltd. - Unknown Date

Source: https://www.keypedia.com/records/483/samsung-biologics-co-ltd/e6eee8b1-6875-48d5-b66c-78c440f4dc88

> FDA 483 for Samsung Biologics Co., Ltd. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Samsung Biologics Co., Ltd.
- Product Type: drugs
- Office Name: Division of Advertising & Promotion 
- Summary: Samsung BioLogics Co., Ltd. in Incheon, Republic of Korea, was inspected for drug substance and drug product manufacturing, revealing significant deficiencies across multiple areas. Issues included compromised HEPA filter integrity, inadequate aseptic techniques, and deficiencies in environmental monitoring and equipment maintenance. Furthermore, the firm exhibited poor control over deviations, CAPA effectiveness, laboratory testing procedures, and process monitoring, indicating a systemic lack of assurance in product quality and compliance.

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## Related Officers

- [Deborah Schmiel, PhD, Biologist](https://www.keypedia.com/people/deborah-schmiel-phd-biologist/52cfc204-9ccb-439c-8227-d5835e18fa0d)
- [Sarah Kennett, PhD, Biologist](https://www.keypedia.com/people/sarah-kennett-phd-biologist/53baba57-7c72-421b-9c20-58fd26ab8e2c)
- [Marion Michaelis, Consumer Safety Officer](https://www.keypedia.com/people/marion-michaelis-consumer-safety-officer/5aa6b8b3-be02-4e0a-8486-30356e36172f)
- [Reyes Candau-Chacon, Ph.D, Microbiologist](https://www.keypedia.com/people/reyes-candau-chacon-phd-microbiologist/7e93758f-43c6-49cb-bd5d-c240f910802d)
- [Monica Markovski, PhD, Staff Fellow](https://www.keypedia.com/people/monica-markovski-phd-staff-fellow/ea9a6a6d-e2e8-4153-a896-eb9b093533e6)

Company: https://www.keypedia.com/companies/samsung-biologics-co-ltd/817b7bc4-2de1-47f4-b552-178303c8da01

Office: https://www.keypedia.com/offices/division-of-advertising-promotion/adcc8282-aca9-4610-955c-e6553c7619b0