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. Specifically,

EMPLOYEE(S) SIGNATURE

DATE ISSUED SEE REVERSE Zhongre n Wu , I nve sti gator OF THIS PAGE 0 7 / 0 5 / 2 019 ~ V LA.J~ - \.._) FORM FDA ◄SJ (09108) PREVIOUS EDITION OBS0t.E"t1' I.NSPECTJONAL OBSERVATJ'ONS PAGE I OF 3 PAGES 008223599DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION DA"TE(S) OF INSPECTION DISTRICT ADDRESS AND PHONE NUMBER 07/01/2019- 07/05/2019 ORAOPQOHQ FEINUMeER 12420 Parklawn Drive, Rm 2032 30032895902 Rockville, MD 20852 [email protected]

NAME AND TITLE OF INDIVIDUAL TO V',HOl,I REPORT ISSUED

Mr. Kun Wu, President STREET ADDRESS FIRM NAME No. 282 Donghuan Road Liuzhou LMZ Co., Ltd. TYPE ESTABLISHMENT INSPECTED CITY, STATE, ZIP COOE, COUNTRY OTC {b)l..f) ~manufacturer Liuzhou, Guangxi, China 545005 your firm failed to perform the growth promotion test for the growth media such as{ fi)l..f) plates you prepared for the microbiological testing. The microbiological testing has been used to monitor the t~b)l..f) (b) (4) I bioburden of the US-market product Your in-house prepared growth media is also used for environmental monitoring, and water quality evaluation.

Observation 3 Laboratory controls do not include the establishment of scientifically sound and appropriate standards and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity. Specifically, 4 a. Your firm failed to conduct the bulk blend uniformity study of the US-markedl(b) < > I {fi)l..f) (b) <4> ~ using statistically sound sampling plan. 4 b. The bulk hold time sh1dy of youq(b) < > ated 6/24/2016 is deficient that insufficient data was included in the study. c. The microbiological method for the purified water testing is deficient that you failed to follow the monograph.

Observation 4

Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for accuracy and completeness. Specifically,

Y o_ur firm failed to review and verify the raw data by a second person when performing the assay of f6H41 l

EMPLOVEE\S) SIGNATURE DATEJSSUEP SEE REVERSE Zhongren Wu, Investigator 07/05/2019 OF THIS PAGE ~

FORM FDA 483 (09/08) PREVIOUS EDlTJON 08SOLET£ L'ISPECTIONAL OBSERVATIONS J>AGE 2 OFJ PAGES 008223599DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINIS1RATION DISTRICT ADDRESS ANO PHONE NUMBER OATE(S) OF INSPECTION ORAOPQOHQ 07/01/2019- 07/05/2019 12420 Parklawn Drive, Rm 2032 FEIN\JMBER Rockville, MD 20852 30032895902 [email protected]

NAME ANO TITt.E OF INOJV!DUAL TO WHOM RB'ORT ISSUED Mr. Kun Wu, President FIRM NAME STREET ADDRESS Liuzhou LMZ Co., Ltd. No. 282 Donghuan Road CITY, STATE. ZJP COOE. COUNTRY TYPE ESTABLISHMENT lNSPECTEO Liuzhou, Guangxi, China 545005 OTC ~6} {'J~ manufacturer

PRODUCTION SYSTEM

Observation 5

Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product. Specifically,

~hite dusts were observed at the cleanedf6f<'I _stations located on the b) C..f) floor. These are the {bf(..f station for the small quantity of powder raw materials including but not limited to bfC4 (b) (4)

Observation 6

The batch production and control records do not include a statement of the actual yield and percentage of theoretical yield at appropriate stages of processing for each batch of drug product produced. Specifically,

Your firm failed to include calculation of theoretical yield and actual yield in each of your batch records, and no action limit is established to initiate deviation jnvestigations. For example, no calculations of the actual yields were included in the batch recordl(b) <4> I

EMPLOYEE(S) SIGNATURE DATE I SSUED SEE REVERSE Zhongren Wu , I nve sti gator 07/05/2019 OF THIS PAGE - FORM FDA ◄&3 (09/03) PllEVIO\JS EDITION OBSOLl!TE 1NSPECTIONAL OBSERVATIONS PAGE 3 OF 3 PAGES