WARNING LETTER Yibin Lihao Bio-technical Co., Ltd. MARCS-CMS 592503 — FEBRUARY 13, 2020
1. Failure to prepare and use production and control records for each intermediate and API batch. Your site produces crude heparin for purification into finished API. During a pre-inspectional call on July 10, 2019, your firm stated to FDA that you had not manufactured any materials for months. At the start of the FDA inspection on July 31, 2019, your firm stated to the investigator that you were not manufacturing crude heparin and were only per forming equipment testing. During a walkthrough of your warehouse, the investigator observed a warehouse employee leaving the warehouse with a fiber drum and inquired about the contents of the drum. Your firm stated that the drum contained (b)(4) bags. However. inspection of the drum revealed two batches of crude heparin manufactured just a few days before the FDA inspection (CU190726, (b)(4) , manufacturing date July 26, 2019, and CU 190727, (b)(4) , manufacturing date July 27, 2019). When asked about manufacturing and testing reco