> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# 6 Observations in Samsung Biologics FDA-483
- URL: https://www.fdaweb.com/6-observations-in-samsung-biologics-fda-483/
- Published: 2023-10-17T12:00:00.000Z
- Updated: 2026-09-14T14:13:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155585

FDA has released the form [FDA-483](https://www.fda.gov/media/173114/download?attachment&ref=fdaweb.com) issued following an 8/21-9/1 inspection at the Samsung Biologics drug manufacturing facility in Incheon, Korea. The six inspection observations are:

- the Manufacturing Scientific Analytical Technology laboratory used to support application submission testing has inadequate controls over data integrity;
- written production and process control procedures are not followed or established, or are deficient;
- failing to adequately establish controls over manufacturing operations and processes;
- failing to perform revalidation of equipment used in the processing of drug products at appropriate intervals;
- the quality unit is inadequate to ensure it is capable of carrying out its roles and responsibilities; and
- failing to adequately maintain facilities.