AQUISEL S.L.U. – FDA Inspection, May 15, 2019

Record Details

This FDA Inspection record concerns AQUISEL S.L.U., with an inspection on May 15, 2019, issued by the Center for Devices and Radiological Health, covering devices.

Company: AQUISEL S.L.U.
Inspection Date: May 15, 2019
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: Stephen R. Souza (Investigator)

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ID · 6bd56066-0093-4b5c-8589-48d4a66562a6

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 1090088
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 820.40(a)Document review, approval by designated individual
21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures

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FDA Inspection

AQUISEL S.L.U.May 15, 2019