# FDA 483 - Samsung Biologics Co., Ltd. - June 09, 2022

Source: https://www.keypedia.com/records/483/samsung-biologics-co-ltd/134cfe7e-fea2-4b96-9e87-ef42c2597d55

> FDA 483 for Samsung Biologics Co., Ltd. on June 09, 2022. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Samsung Biologics Co., Ltd.
- Inspection Date: 2022-06-09
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: This FDA Form 483 was issued to Samsung Biologics Co., Ltd. (SBL) in Incheon, Korea, a drug substance and drug product manufacturer, following an inspection from June 2 to June 9, 2022. The report lists three observations.

Observation 1 notes that the endotoxin detection method is unreliable. During investigations of endotoxin non-conformance results (NCR), re-testing with Endotoxin Specific (ES) buffer suggested interference. Some re-tests with ES buffer resulted in invalid assays due to positive product control (PPC) spike recovery exceeding acceptance criteria. A proposed CAPA (006327) suggests using ES buffer as a retest remediation without initiating an NCR for routine in-process and release testing when initial testing with LAL Reagent results in an NCR, but this does not resolve the assay variability due to interference.

Observation 2 states that written procedures for cleaning and maintenance are inadequate or not followed. Specifically, SOP MFP-00290 "Aseptic Operation and Sanitization for DP RABS & Grade A" Version 32 lacks a sequence for RABS cleaning steps. Operators were observed spraying RABS surfaces first and then cleaning HEPA filters, contrary to the SOP's instruction to begin from the top surfaces. Additionally, operators were seen brushing their gowning while both RABS doors were open during cleaning.

Observation 3 indicates that investigations into assay failures

## Related Documents

- [483 - 2025-05-27](https://www.keypedia.com/records/483/samsung-biologics-co-ltd/b3a6afca-acc1-42d3-9eaa-a9c039d1bb0a)
- [483 - 2021-08-24](https://www.keypedia.com/records/483/samsung-biologics-co-ltd/f660cf8a-50b8-4766-b37d-4605324fd16b)
- [483 - 2022-06-09](https://www.keypedia.com/records/483/samsung-biologics-co-ltd/caf2bc64-dcd8-4d80-a40d-ca04258e6266)
- [483 - 2018-03-14](https://www.keypedia.com/records/483/samsung-biologics-co-ltd/ce260ba9-5da0-4986-9b6e-3fee4fc334d5)
- [483 - 2018-06-26](https://www.keypedia.com/records/483/samsung-biologics-co-ltd/f30ce007-aebc-4adb-b5d0-3fe2fcb25da0)

## Related Officers

- [Madushini N. Dharmasena](https://www.keypedia.com/people/madushini-n-dharmasena/c6dbff15-4c5f-475e-8ec1-581d8e65f76c)

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

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c