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.
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