1. FDA GMP Certification

FDA（Food and Drug Administration）It is a food and drug regulatory agency authorized by the U.S. Congress to supervise and regulate food, drugs, medical devices, cosmetics, and other public health-related products. The FDA's primary mission is to ensure the safety, effectiveness, and proper labeling of these products when used by the public.

In common usage, "FDA certified" is not an official term used by the FDA. People often use "FDA certification" to refer to the following three situations:
FDA Registration:For food, drug and medical device companies exporting to the United States, they must register with the FDA, including the listing of the company and products. If the registration is not completed, the customs will not be cleared. This is a mandatory requirement;

FDA Testing:FDA testing usually refers to the safety testing of food contact materials, product packaging materials, biocompatibility testing and clinical safety testing of medical products. These tests are designed to ensure product safety and compliance with FDA standards;

FDA approved:FDA approvals are primarily in the area of pharmaceuticals. When a drug has undergone rigorous research, testing, and evaluation, it is approved by the FDA before it can be sold and used in the U.S. market.

2. Project Objectives
Durst DST helps companies to pass the US FDA certification within the time agreed with the company, and helps companies to improve the legal procedures for their products to enter the US and European markets, so that their products can enter the US market smoothly. The legal listing of Chinese domestic products in the European and American markets will have a positive impact on the products in the domestic market and other international markets.

3. service mode

1. Gap assessment of the existing quality management system and comparison with FDA regulations;

2. Overall design, understand the existing company structure, production system, QA system, QC system, supply chain system, engineering system, etc;

3. FDA training, the company's relevant responsible personnel and employees for FDA drug general regulations training;

4. Special training on FDA regulations, special training on FDA drug regulations for relevant persons in charge of the company;

5. Collect the company's existing quality documents and improve the quality document system;

6. Implementation of quality documentation system;

7. Check the effectiveness of the system;

8. Check the effectiveness of the system, before the FDA to audit, arrange the company's reviewers to conduct a simulation audit;

9. Accompany FDA to review the factory and translate;

10. Assist enterprises to rectify the non-conformances proposed by FDA review plants until FDA closes the non-conformances.

4. FDA factory inspection experience sharing:

The greater the amount of production and export to the United States, the more users complain, and the greater the possibility of being inspected by FDA;

2. However, enterprises in China (including Hong Kong, Macao and Taiwan), whether they are Class I, Class II or Class III, have a very high probability of being inspected by FDA, and our company has come into contact with a large number of cases of low-risk product inspection;

3. All inspection fees, air tickets, travel, five-star hotels, meals and other expenses are borne by FDA;

FDA usually notifies the factory 1-3 months in advance, but will not notify the specific date of the factory;

5. Usually FDA only comes to one person, normal audit 4 days;

6. Important documents such as quality manuals and procedure documents shall be translated into English, and environmental sanitation shall be well done;

7. FDA more emphasis on internal audit and records, the relevant departments of the signature;

8. FDA attaches great importance to laws and regulations, professional knowledge, operating guidelines and other staff training and implementation, signature;

9. If there is any non-conformity, the auditor will issue a 483 form on site;

10. For all questions raised by the auditor, the enterprise must submit a written reply within the specified time, the sooner the better;

11. For major non-conformations, the auditor will issue a warning letter (Warning letter) on the spot, and the enterprise must complete the rectification within the specified time.

4. FDA Case

1. FDA Project of a Pharmaceutical Enterprise in Zhejiang

2. FDA Project of a Pharmaceutical Enterprise in Guangdong

3. Injection FDA Project of a Pharmaceutical Company in Sichuan

4. FDA Project of Raw Material Drug of a Biological Enterprise in Chengdu

5. FDA Project of Sterile Preparations of a Pharmaceutical Enterprise in Hubei Province

6. OTC FDA Project of a Famous Central Enterprise in Shenzhen

7. FDA Project of a Pharmaceutical Enterprise in Fujian

8. API FDA Project of a Pharmaceutical Company in Jiangsu Province

9. Other FDA Program Customers

If you need FDA certification related services, please contact 18826007039/13326993435 (WeChat with the same number) ~