FDA 483 - Daizo Corporation - November 06, 2023

This FDA Form 483 was issued to Daizo Corporation, an OTC Drug Manufacturer located at 704 Yodomizu-Cho, Fushimi, Kyoto, Kyoto, 613-0916 Japan. The inspection was conducted from October 30, 2023, to November 6, 2023, by Seneca D Toms, National Expert. Atsuhiko Kimura, Kyoto Plant Manager, was the individual to whom the report was issued.

The inspection revealed three observations:

1. **Deficient Laboratory Records:** Laboratory records lacked complete data from testing. Specifically, repeated gas chromatography (GC) sample analyses were observed on at least four occasions in 2023, including for two drug product lots manufactured for the US market. The reason for these repeated analyses was not documented, and only the repeated results were reported in finished OTC drug product records.

2. **Inadequate Computer System Controls:** Appropriate controls were not exercised over computers or related systems to ensure that changes in master production and control records were instituted only by authorized personnel. There were no written procedures for reviewing audit trails associated with the GC software used to analyze products, including those for the US market, to ensure data integrity. Quality Control personnel reportedly do not review audit trails.

3. **Insufficient Laboratory Controls for Specifications:** Laboratory controls did not include scientifically sound and appropriate specifications to assure drug product quality. The firm lacked data to support