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mercredi 4 mars 2020

WARNING LETTER Chemland Co., Ltd. MARCS-CMS 593158 — FEBRUARY 11, 2020

1. Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)).
Your quality unit (QU) lacked adequate responsibilities and authorities to assure reliable operations. For example:
A. You failed to ensure the audit trail feature was enabled on your Inductively Coupled Plasma - Optical Emission Spectrometry (lCP-OES) instrument to track creation, modification, or deletion of data. This instrument was used to obtain assay results for your drug products.
B. You stored your master batch records as unlocked Excel files which were open to alteration, duplication, and deletion by unauthorized personnel.
C. Your analysts used open Excel files for documenting sample preparation information and final calculations. These records were not retained. For example, your personnel admitted during the inspection that records and data, such as volume of test solution, sample weight, and final calculations, are not retained.
Manufacturing data must be retained to support CGMP activities including but not limited to your batch disposition decisions, stability studies, and investigations.