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# 12 Observations in Celltrion FDA-483
- URL: https://www.fdaweb.com/12-observations-in-celltrion-fda-483/
- Published: 2018-04-13T12:00:00.000Z
- Updated: 2026-09-14T23:59:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141213

FDA has released the FDA-483 issued following a 5/22-26/17 and 5/29-6/2/17 inspection at the Celltrion drug manufacturing facility in Incheon, Korea. The 12 inspection observations were: 

- · 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 have procedures designed to prevent microbiological contamination of drug products purporting to be sterile to include adequate validation of the sterilization process;
- · 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 determine that the firm’s manufacturing process can reproducibly manufacture drug substance meeting its predetermined quality attributes;
- laboratory records do not include complete data derived from all tests, examinations, and assay 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
- batch production records do not contain complete information relating to the production and control of each batch.