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# 12 Observations in Korea Celltrion Inspection
- URL: https://www.fdaweb.com/12-observations-in-korea-celltrion-inspection/
- Published: 2017-09-06T12:00:00.000Z
- Updated: 2026-09-14T22:47:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139557

FDA has released the FDA-483 issued following a 5/22-6/2 inspection at Celltrion, an Inchon, Korea, sterile injectable drug product and drug substance manufacturer. The [form](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM574767.pdf?ref=fdaweb.com) lists the inspection observations as: 

- failing to thoroughly review any unexplained discrepancy, whether or not the batch has already been distributed;
- failing to establish and follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
- failing to include adequate validation of the sterilization process in procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
- aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
- aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions;
- equipment used in the manufacturing areas of a drug product is not of appropriate design;
- failing to demonstrate that a manufacturing process can reproducibly manufacture drug substance meetings its predetermined quality attributes;
- laboratory records do not include complete data derived from all tests, examinations, and assays necessary to assure compliance with established specifications and standards;
- failing to exercise appropriate controls over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel;
- failing to follow procedures for preparation of master production and control records;
- failing to document data contemporaneously; and
- failing to have batch production records contain complete information relating to the production and control of each batch.