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Your Best Resource |
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When it comes to meeting FDA regulatory and compliance requirements experience counts, and we deliver |
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Compliance Audit |
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● GLP/GMP/ QSR, and ISO 13485 compliance audits ● Response to FD-483’s and warning letters ● Supplier and subcontractors audit ● Site change and qualification audit ● Mock FDA audit |
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With everyday workload and changes in FDA compliance requirements even with enough experienced resources on board, sometimes it is difficult to keep up with current requirements. Our extensive experience in FDA regulated industries has enabled us to provide the most detailed compliance audit services for our clients.
We have performed numerous QSR, GMP and GLP audits on medical device companies, Biotech companies, drug products and API manufacturers, OTC and nutritional supplement manufacturers, and cosmetic/drug manufacturers.
QICI can help you with:
● Compliance audits ● Response to FD-483’s and warning letters ● Supplier/Vendor and subcontractors audits ● Site change qualification audits ● Mock FDA inspection ● ISO 9001 and 13485 audits and assessments for ISO registration
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Quest International Consulting 26180 Enteprise Way Suite 300 Lake Forest, CA 92630 USA Phone: 949-297-4445 Fax: 949-215-3434
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Full Auditing services: |
