Samsung Biologics Co., Ltd.

Form 483 · Y consu-gu, South Korea

Observations: 3
Pages: 4
FEI number: 3010479596

In short: FDA issued a Form 483 with 3 observations to Samsung Biologics Co., Ltd. in Y consu-gu, Jncheon (FEI 3010479596).

What FDA observed

Preview: the opening words of each observation

01
The responsibilities and procedures applicable to the quality control unit were not always fully followed. The…
02
Observation 2: scanned text, readable in the full document.
03
Observation 3: scanned text, readable in the full document.

The full 483

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This inspection in context

The firm

Samsung Biologics Co., Ltd. history

All 14 documents on file for this site, in date order, with what was cited at each inspection.

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Questions about this 483

What did FDA find at Samsung Biologics Co., Ltd.?

FDA listed 3 observations on this Form 483. The opening words of each observation are shown on this page.

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