X-CEL CONTACTS, INC. – FDA Inspection, May 22, 2017

Record Details

This FDA Inspection record concerns X-CEL CONTACTS, INC., with an inspection on May 22, 2017, issued by the Center for Devices and Radiological Health, covering devices.

Company: X-CEL CONTACTS, INC.
Inspection Date: May 22, 2017
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: Benjamin W. Anderson (Issuing Officer)

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ID · 1807171e-e343-40b8-9fcd-9c61d414814d

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1012794
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 820.100(a)Lack of or inadequate procedures

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FDA Inspection

X-CEL CONTACTS, INC.May 22, 2017