Company dynamics

FDA ONLINE REVIEW

       During April.06--08,2022, total three days, US FDA officer Raccine Campbell  inspection our factory via ZOOM, it names: Foreign Remote Regulatory Assessment  ( FRRA). 

       Prior to FRRA, Raccine Campbell request us to upload via the provided link the following documents

 that pertain to the product(s) we export to the United States;

Company and Product Details

Process Flow Diagram

Product Labels

HACCP Plan

Food Safety Plan

Allergen Program

Recall Procedure

     The following are general documents that  Raccine Campbell review during the assessment depending 

on the applicable FDA regulations:

Factory Diagram

Supplier Program

Sanitation Monitoring Records

Laboratory Analysis

Training Records (any FDA training certificates)

      During the meeting with FDA, our production manager, quality department manager, sales manager has answered all the questions from Raccine Campbell, and upload the record which happen at FEb.16 and 

Feb.18, ( these two days we produced drinks for US customer) :  the production process record, cleaning 

workshop record, microbiology record, operator desk sanitary verificatin record, the air in the filling and

 sealing room inspection record, and raw materials acceptance record, etc. 

     After finish checking the records, Raccine Campbell asked us to take video for the workshop, and all the machines which are for production, and the produciton producing.  when he watched these video, asked us some questions, and we replied him.

     At Apr.08, 14:00pm,  Raccine Campbell has finished all FRRA for our facotry, and he said he satisfied with our facotry. 



    During 2016, July.21--22, FDA officer Rohn Robertson came to our facotry and inspection our factory on 

site. he also check all our records and workshop and production process on site.  At the conclusion of the

 summing-up session, he said the FDA did not see a mandate for food facilities to certify food safety

 management systems, but for safety and hygiene requirements for food production. He said he was

 satisfied with the process management in our factory.


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Contact Us

Contact: XIAMEN ELISHA MINERAL WATER CO.,LTD

Phone: 0086-592-6037031

Tel: 0086-592-7395501

E-mail: sale@elisha.com.cn

Add: NO 35, RD 1, HongTangTou, XiKe Town, TongAn, XiaMen, P.R.China