008223599DEPARTMENT OF HEALTH AND HUMAN SERV ICES FOOD AND DRUG ADMINlSTRA TION DISTRICT ADDRESS ANO PHONE NUMBER DATo(S) O F INSPECTION ORAOPQOHQ 07/0 l/2019- 07/05/20 19 1. 2420 Parklawn Drive, Rm 2032 FEI ..U MBER Rockville, MD 20852 30032895902
[email protected] NAME ANO TITLE OF INDI\/IDUAI. TO WHOM REPORT ISSUED Mr. Kun Wu, President FJRMNAME STREET AOORESS Liuzhou LMZ Co., Ltd. No. 282 Donghuan Road CJTY. STATE. ZIPCOOE.COUNTRY TYPE ESTABUSHME>IT INSPECTED Liu zhou, Guangxi, Ch ina 545005 OTC {C6f<-l manufacturer This document lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional observations, and do not represent a final Agency determination regarding your compliance. If you have an objection regarding an observation, or have implemented, or plan to implement, corrective action in response to an observation, you may discuss the objection or action with the FDA representative(s) during the inspection or submit this information to FDA at the address above. If you have any questions, please contact FDA at the phone number and address above. DURING AN INSPECTION OF YOUR FIRM WE OBSERVED: QUALITY SYSTEM Observation 1 The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed_ Specifically, Your fi rm failed to establish written operating procedures for many manufacturing processes including but not limited to facility/equipment maintenance programs, stability studies, and the non-viable particulate monitoring. LABORATORY SYSTEM Observation 2 Verification of the suitability of the testing methods is deficient in that they are not documented on the laboratory records.