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# 10 Observations in Toyobo FDA-483
- URL: https://www.fdaweb.com/10-observations-in-toyobo-fda-483/
- Published: 2021-09-07T12:00:00.000Z
- Updated: 2026-09-14T17:13:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150095

FDA has released the FDA-483 issued following a 2/15-2/25 inspection at Toyobo Co., Otsu, Shiga, Japan. The 10 inspection observations on the document are: 

- failing to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed;
- aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
- production personnel were not practicing good sanitation and health habits;
- 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 follow written production and process control procedures in the execution of production and process control functions;
- failing to include conclusions and follow-up in the written records of investigations into unexplained discrepancies;
- failing to verify under actual conditions of use the suitability of all testing materials;
- failing to put in writing and fully follow the responsibilities and procedures applicable to the quality control unit;
- failing to have batch production and control records to include the weights and measures of components used in the course of processing each batch of drug product produced;
- failing to exercise appropriate controls over computers or related systems to assure that changes in master production and control records are instituted only by authorized personnel.