Korean OTC Manufacturer Warned for Data Integrity Failures

March 19, 2020

The FDA issued a warning letter to Korean OTC drugmaker Chemland for multiple data integrity and other GMP violations.

An agency inspection of the Gyeonggi-Do facility found that master batch records were saved as Excel files that could be copied, changed and deleted by unauthorized personnel, and analysts did not save Excel files used to document sample preparation and final calculations.

Chemland didn’t validate its manufacturing processes for certain over-the-counter drug products. The facility also lacked written cleaning procedures and cleaning validations for some equipment.

The firm was also cited for basing the shelf life for its OTC drug products on insufficient stability data. It used just one batch of each product in its accelerated and long-term stability studies.

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