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

FDA 483_RESPONSE for Advanced Infusion Solutions on October 27, 2015. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA 483_RESPONSE for Advanced Infusion Solutions on October 27, 2015. Product: Devices. Access full analysis and detailed observations.

Violation Codes

FD&C Act 501(a)(2)(B)

FD&C Act 503A

21 U.S.C. 374

FD&C Act 501(a)(2)(A)

FD&C Act 503A(a)

FD&C Act 503B

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Record Information

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

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

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