FDA factory inspection

FDA Cosmetic Factory Inspection Response
Method/Steps:
The gap between the existing quality management system and regulatory requirements
The overall design of the consulting process, including on-site rectification, documentation system, and application rectification;
Collect existing document materials: quality manual, procedure documents, work instructions, process documents, inspection procedures, records, etc
Based on FDA factory inspection requirements, document review, inspection of GMP throughout the production process, and maintenance of GMP content for equipment and facilities, consultants and relevant personnel of the enterprise work together to carry out file system modifications;
Assist enterprises in identifying and rectifying deficiencies in their workshops and warehouses;
Provide training on auditing skills for enterprise personnel;
Check the effectiveness of the system and arrange for our company's reviewers to conduct a simulated audit before the FDA comes for review;
Accompanying FDA factory inspections;
Assist enterprises in rectifying non conformities

Food companies exporting to the United States may be subject to factory inspections by the US FDA after undergoing corporate registration. The factory inspection will be conducted by American reviewers, with a focus on on-site GMP, SSOP, and HACCP plans, as well as batch records. If the review fails or you do not accept the review, it will result in you losing the US market.

Provide FDA factory inspection guidance, audit accompaniment, and translation services.
Professional services for responding to FDA spot checks, factory audits, improvements, and accompanying audits:
The gap between the existing quality management system and regulatory requirements
The overall design of the consulting process, including on-site rectification, documentation system, and application rectification;
Based on FDA audit requirements, document review, inspection of GMP throughout the production process, and maintenance of GMP content for equipment and facilities, consultants and relevant personnel of the enterprise work together to carry out file system adjustments;
Assist enterprises in identifying and rectifying deficiencies in their workshops and warehouses;
Provide training on auditing skills for enterprise personnel;
Check the effectiveness of the system by arranging reviewers to conduct simulated audits before the FDA comes for review;
Accompanying FDA factory inspections;
Assist enterprises in rectifying non conformities

What should pharmaceutical companies do when they receive a factory inspection notice from the FDA authorities
Professional response to FDA factory inspection, audit, improvement, and audit accompanying services. FDA factory inspection follows OTC quality system guidelines for compliance guidance
OTC Quality System Guidelines Compliance Guidelines:
1. The gap between the existing quality management system and regulatory requirements
2. The overall design of the consulting process, including on-site rectification, documentation system, and application rectification;
3. Collect existing document materials: quality manual, procedure documents, work instructions, process documents, inspection procedures, records, etc
4. Based on FDA audit requirements, document review, inspection of GMP throughout the production process, and maintenance of GMP content for equipment and facilities, consultants and relevant personnel of the enterprise work together to carry out file system modifications;
5. Assist enterprises in identifying and rectifying deficiencies in their workshops and warehouses;
6. Provide training on auditing skills for enterprise personnel;
7. Check the effectiveness of the system, and arrange for our company's reviewers to conduct simulated audits before the FDA comes for review;