FDA 483_RESPONSE - Advanced Infusion Solutions - October 27, 2015

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This 483 RESPONSE record concerns Advanced Infusion Solutions, with an inspection on October 27, 2015, issued by the Office of Health Technology 1 (Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices), covering devices.

Company: Advanced Infusion Solutions
Inspection Date: October 27, 2015
Product Type: Devices
Office: Office of Health Technology 1 (Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices)
People: Marie Buen-Bigornia (Investigator )
Amanda Edmonds
Sheldon T. Bradshaw
Ruth P. Dixon (Program Division Director)
Charles R. Bell

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ID · 7793eada-403c-4d1a-9f7d-ad340dfa793c

Violation Codes6

FD&C Act 501(a)(2)(B)FD&C Act 503A21 U.S.C. 374FD&C Act 501(a)(2)(A)FD&C Act 503A(a)FD&C Act 503B

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