WARNING LETTER Sunstar Guangzhou Ltd. MARCS-CMS 592906 — JANUARY 22, 2020
4. Failure to establish an adequate quality control unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. (21 CFR 211.22(a) and 211.22(d)).
Your quality unit (QU) failed to ensure that you have adequate procedures and did not provide adequate oversight of your manufacturing activities. For example: ·
• You lack adequate control over the issuance, use, and reconciliation of manufacturing batch records and equipment maintenance sheets. Uncontrolled copies of manufacturing batch records and in-process control forms were pre-printed and kept in a room with unrestricted access.
• Several test reports of your drug product assay were reviewed and the raw data for the standard curve could not be located. It was noted that scrap pieces of paper were used to record data which was later entered to calculate the (b)(4) concentration for the assay test.
