209570Orig1s000 - Food and Drug Administration · Dni Substance Dill Product Process Microbiolo...
Transcript of 209570Orig1s000 - Food and Drug Administration · Dni Substance Dill Product Process Microbiolo...
![Page 1: 209570Orig1s000 - Food and Drug Administration · Dni Substance Dill Product Process Microbiolo Facilities Bio hannaceutics Regulat01Y Business Process Mana er Laborato OTR Environmental](https://reader034.fdocuments.net/reader034/viewer/2022050104/5f42df0e624fd42aa2741f43/html5/thumbnails/1.jpg)
CENTER FOR DRUG EVALUATION AND RESEARCH
APPLICATION NUMBER:
209570Orig1s000
PRODUCT QUALITY REVIEW(S)
![Page 2: 209570Orig1s000 - Food and Drug Administration · Dni Substance Dill Product Process Microbiolo Facilities Bio hannaceutics Regulat01Y Business Process Mana er Laborato OTR Environmental](https://reader034.fdocuments.net/reader034/viewer/2022050104/5f42df0e624fd42aa2741f43/html5/thumbnails/2.jpg)
![Page 3: 209570Orig1s000 - Food and Drug Administration · Dni Substance Dill Product Process Microbiolo Facilities Bio hannaceutics Regulat01Y Business Process Mana er Laborato OTR Environmental](https://reader034.fdocuments.net/reader034/viewer/2022050104/5f42df0e624fd42aa2741f43/html5/thumbnails/3.jpg)
![Page 4: 209570Orig1s000 - Food and Drug Administration · Dni Substance Dill Product Process Microbiolo Facilities Bio hannaceutics Regulat01Y Business Process Mana er Laborato OTR Environmental](https://reader034.fdocuments.net/reader034/viewer/2022050104/5f42df0e624fd42aa2741f43/html5/thumbnails/4.jpg)
![Page 5: 209570Orig1s000 - Food and Drug Administration · Dni Substance Dill Product Process Microbiolo Facilities Bio hannaceutics Regulat01Y Business Process Mana er Laborato OTR Environmental](https://reader034.fdocuments.net/reader034/viewer/2022050104/5f42df0e624fd42aa2741f43/html5/thumbnails/5.jpg)
![Page 6: 209570Orig1s000 - Food and Drug Administration · Dni Substance Dill Product Process Microbiolo Facilities Bio hannaceutics Regulat01Y Business Process Mana er Laborato OTR Environmental](https://reader034.fdocuments.net/reader034/viewer/2022050104/5f42df0e624fd42aa2741f43/html5/thumbnails/6.jpg)
![Page 7: 209570Orig1s000 - Food and Drug Administration · Dni Substance Dill Product Process Microbiolo Facilities Bio hannaceutics Regulat01Y Business Process Mana er Laborato OTR Environmental](https://reader034.fdocuments.net/reader034/viewer/2022050104/5f42df0e624fd42aa2741f43/html5/thumbnails/7.jpg)
![Page 8: 209570Orig1s000 - Food and Drug Administration · Dni Substance Dill Product Process Microbiolo Facilities Bio hannaceutics Regulat01Y Business Process Mana er Laborato OTR Environmental](https://reader034.fdocuments.net/reader034/viewer/2022050104/5f42df0e624fd42aa2741f43/html5/thumbnails/8.jpg)
![Page 9: 209570Orig1s000 - Food and Drug Administration · Dni Substance Dill Product Process Microbiolo Facilities Bio hannaceutics Regulat01Y Business Process Mana er Laborato OTR Environmental](https://reader034.fdocuments.net/reader034/viewer/2022050104/5f42df0e624fd42aa2741f43/html5/thumbnails/9.jpg)
![Page 10: 209570Orig1s000 - Food and Drug Administration · Dni Substance Dill Product Process Microbiolo Facilities Bio hannaceutics Regulat01Y Business Process Mana er Laborato OTR Environmental](https://reader034.fdocuments.net/reader034/viewer/2022050104/5f42df0e624fd42aa2741f43/html5/thumbnails/10.jpg)
![Page 11: 209570Orig1s000 - Food and Drug Administration · Dni Substance Dill Product Process Microbiolo Facilities Bio hannaceutics Regulat01Y Business Process Mana er Laborato OTR Environmental](https://reader034.fdocuments.net/reader034/viewer/2022050104/5f42df0e624fd42aa2741f43/html5/thumbnails/11.jpg)
![Page 12: 209570Orig1s000 - Food and Drug Administration · Dni Substance Dill Product Process Microbiolo Facilities Bio hannaceutics Regulat01Y Business Process Mana er Laborato OTR Environmental](https://reader034.fdocuments.net/reader034/viewer/2022050104/5f42df0e624fd42aa2741f43/html5/thumbnails/12.jpg)
![Page 13: 209570Orig1s000 - Food and Drug Administration · Dni Substance Dill Product Process Microbiolo Facilities Bio hannaceutics Regulat01Y Business Process Mana er Laborato OTR Environmental](https://reader034.fdocuments.net/reader034/viewer/2022050104/5f42df0e624fd42aa2741f43/html5/thumbnails/13.jpg)
![Page 14: 209570Orig1s000 - Food and Drug Administration · Dni Substance Dill Product Process Microbiolo Facilities Bio hannaceutics Regulat01Y Business Process Mana er Laborato OTR Environmental](https://reader034.fdocuments.net/reader034/viewer/2022050104/5f42df0e624fd42aa2741f43/html5/thumbnails/14.jpg)
![Page 15: 209570Orig1s000 - Food and Drug Administration · Dni Substance Dill Product Process Microbiolo Facilities Bio hannaceutics Regulat01Y Business Process Mana er Laborato OTR Environmental](https://reader034.fdocuments.net/reader034/viewer/2022050104/5f42df0e624fd42aa2741f43/html5/thumbnails/15.jpg)
![Page 16: 209570Orig1s000 - Food and Drug Administration · Dni Substance Dill Product Process Microbiolo Facilities Bio hannaceutics Regulat01Y Business Process Mana er Laborato OTR Environmental](https://reader034.fdocuments.net/reader034/viewer/2022050104/5f42df0e624fd42aa2741f43/html5/thumbnails/16.jpg)
![Page 17: 209570Orig1s000 - Food and Drug Administration · Dni Substance Dill Product Process Microbiolo Facilities Bio hannaceutics Regulat01Y Business Process Mana er Laborato OTR Environmental](https://reader034.fdocuments.net/reader034/viewer/2022050104/5f42df0e624fd42aa2741f43/html5/thumbnails/17.jpg)
![Page 18: 209570Orig1s000 - Food and Drug Administration · Dni Substance Dill Product Process Microbiolo Facilities Bio hannaceutics Regulat01Y Business Process Mana er Laborato OTR Environmental](https://reader034.fdocuments.net/reader034/viewer/2022050104/5f42df0e624fd42aa2741f43/html5/thumbnails/18.jpg)
![Page 19: 209570Orig1s000 - Food and Drug Administration · Dni Substance Dill Product Process Microbiolo Facilities Bio hannaceutics Regulat01Y Business Process Mana er Laborato OTR Environmental](https://reader034.fdocuments.net/reader034/viewer/2022050104/5f42df0e624fd42aa2741f43/html5/thumbnails/19.jpg)
![Page 20: 209570Orig1s000 - Food and Drug Administration · Dni Substance Dill Product Process Microbiolo Facilities Bio hannaceutics Regulat01Y Business Process Mana er Laborato OTR Environmental](https://reader034.fdocuments.net/reader034/viewer/2022050104/5f42df0e624fd42aa2741f43/html5/thumbnails/20.jpg)
GerlieGieser
Digitally signed by Gerlie Gieser
Date: 6/02/2017 11:55:27AM
GUID: 507592ba00003d190b2ea34fe8fb8ccb
ElsbethChikhale
Digitally signed by Elsbeth Chikhale
Date: 6/02/2017 12:13:34PM
GUID: 50743ccc000031928b54eba1769a5df9
11 Page(s) has been Withheld in Full as b4 (CCI/TS) immediately following this page
![Page 21: 209570Orig1s000 - Food and Drug Administration · Dni Substance Dill Product Process Microbiolo Facilities Bio hannaceutics Regulat01Y Business Process Mana er Laborato OTR Environmental](https://reader034.fdocuments.net/reader034/viewer/2022050104/5f42df0e624fd42aa2741f43/html5/thumbnails/21.jpg)
![Page 22: 209570Orig1s000 - Food and Drug Administration · Dni Substance Dill Product Process Microbiolo Facilities Bio hannaceutics Regulat01Y Business Process Mana er Laborato OTR Environmental](https://reader034.fdocuments.net/reader034/viewer/2022050104/5f42df0e624fd42aa2741f43/html5/thumbnails/22.jpg)
![Page 23: 209570Orig1s000 - Food and Drug Administration · Dni Substance Dill Product Process Microbiolo Facilities Bio hannaceutics Regulat01Y Business Process Mana er Laborato OTR Environmental](https://reader034.fdocuments.net/reader034/viewer/2022050104/5f42df0e624fd42aa2741f43/html5/thumbnails/23.jpg)
![Page 24: 209570Orig1s000 - Food and Drug Administration · Dni Substance Dill Product Process Microbiolo Facilities Bio hannaceutics Regulat01Y Business Process Mana er Laborato OTR Environmental](https://reader034.fdocuments.net/reader034/viewer/2022050104/5f42df0e624fd42aa2741f43/html5/thumbnails/24.jpg)
![Page 25: 209570Orig1s000 - Food and Drug Administration · Dni Substance Dill Product Process Microbiolo Facilities Bio hannaceutics Regulat01Y Business Process Mana er Laborato OTR Environmental](https://reader034.fdocuments.net/reader034/viewer/2022050104/5f42df0e624fd42aa2741f43/html5/thumbnails/25.jpg)
![Page 26: 209570Orig1s000 - Food and Drug Administration · Dni Substance Dill Product Process Microbiolo Facilities Bio hannaceutics Regulat01Y Business Process Mana er Laborato OTR Environmental](https://reader034.fdocuments.net/reader034/viewer/2022050104/5f42df0e624fd42aa2741f43/html5/thumbnails/26.jpg)
![Page 27: 209570Orig1s000 - Food and Drug Administration · Dni Substance Dill Product Process Microbiolo Facilities Bio hannaceutics Regulat01Y Business Process Mana er Laborato OTR Environmental](https://reader034.fdocuments.net/reader034/viewer/2022050104/5f42df0e624fd42aa2741f43/html5/thumbnails/27.jpg)
![Page 28: 209570Orig1s000 - Food and Drug Administration · Dni Substance Dill Product Process Microbiolo Facilities Bio hannaceutics Regulat01Y Business Process Mana er Laborato OTR Environmental](https://reader034.fdocuments.net/reader034/viewer/2022050104/5f42df0e624fd42aa2741f43/html5/thumbnails/28.jpg)
![Page 29: 209570Orig1s000 - Food and Drug Administration · Dni Substance Dill Product Process Microbiolo Facilities Bio hannaceutics Regulat01Y Business Process Mana er Laborato OTR Environmental](https://reader034.fdocuments.net/reader034/viewer/2022050104/5f42df0e624fd42aa2741f43/html5/thumbnails/29.jpg)
![Page 30: 209570Orig1s000 - Food and Drug Administration · Dni Substance Dill Product Process Microbiolo Facilities Bio hannaceutics Regulat01Y Business Process Mana er Laborato OTR Environmental](https://reader034.fdocuments.net/reader034/viewer/2022050104/5f42df0e624fd42aa2741f43/html5/thumbnails/30.jpg)
![Page 31: 209570Orig1s000 - Food and Drug Administration · Dni Substance Dill Product Process Microbiolo Facilities Bio hannaceutics Regulat01Y Business Process Mana er Laborato OTR Environmental](https://reader034.fdocuments.net/reader034/viewer/2022050104/5f42df0e624fd42aa2741f43/html5/thumbnails/31.jpg)
![Page 32: 209570Orig1s000 - Food and Drug Administration · Dni Substance Dill Product Process Microbiolo Facilities Bio hannaceutics Regulat01Y Business Process Mana er Laborato OTR Environmental](https://reader034.fdocuments.net/reader034/viewer/2022050104/5f42df0e624fd42aa2741f43/html5/thumbnails/32.jpg)
YongWang
Digitally signed by Yong Wang
Date: 6/05/2017 05:04:06PM
GUID: 508da7210002a01861739fd87b35adb9
BalajeeShanmugam
Digitally signed by Balajee Shanmugam
Date: 6/05/2017 08:36:37PM
GUID: 50758d5000003c1b1962e036ea11002c
![Page 33: 209570Orig1s000 - Food and Drug Administration · Dni Substance Dill Product Process Microbiolo Facilities Bio hannaceutics Regulat01Y Business Process Mana er Laborato OTR Environmental](https://reader034.fdocuments.net/reader034/viewer/2022050104/5f42df0e624fd42aa2741f43/html5/thumbnails/33.jpg)
![Page 34: 209570Orig1s000 - Food and Drug Administration · Dni Substance Dill Product Process Microbiolo Facilities Bio hannaceutics Regulat01Y Business Process Mana er Laborato OTR Environmental](https://reader034.fdocuments.net/reader034/viewer/2022050104/5f42df0e624fd42aa2741f43/html5/thumbnails/34.jpg)
![Page 35: 209570Orig1s000 - Food and Drug Administration · Dni Substance Dill Product Process Microbiolo Facilities Bio hannaceutics Regulat01Y Business Process Mana er Laborato OTR Environmental](https://reader034.fdocuments.net/reader034/viewer/2022050104/5f42df0e624fd42aa2741f43/html5/thumbnails/35.jpg)
YongWang
Digitally signed by Yong Wang
Date: 8/11/2017 09:49:02AM
GUID: 508da7210002a01861739fd87b35adb9
BalajeeShanmugam
Digitally signed by Balajee Shanmugam
Date: 8/11/2017 11:03:09AM
GUID: 50758d5000003c1b1962e036ea11002c
![Page 36: 209570Orig1s000 - Food and Drug Administration · Dni Substance Dill Product Process Microbiolo Facilities Bio hannaceutics Regulat01Y Business Process Mana er Laborato OTR Environmental](https://reader034.fdocuments.net/reader034/viewer/2022050104/5f42df0e624fd42aa2741f43/html5/thumbnails/36.jpg)
![Page 37: 209570Orig1s000 - Food and Drug Administration · Dni Substance Dill Product Process Microbiolo Facilities Bio hannaceutics Regulat01Y Business Process Mana er Laborato OTR Environmental](https://reader034.fdocuments.net/reader034/viewer/2022050104/5f42df0e624fd42aa2741f43/html5/thumbnails/37.jpg)