R.E.C. Manufacturing Corp. – FDA Inspection, Feb 26, 2019

Record Details

This FDA Inspection record concerns R.E.C. Manufacturing Corp., with an inspection on February 26, 2019, issued by the Center for Devices and Radiological Health, covering devices.

Company: R.E.C. Manufacturing Corp.
Inspection Date: February 26, 2019
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: Sara M. Onyango (Issuing Officer)

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ID · f321f7f5-2d55-414d-b76c-25c770791d38

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number: 1080639
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 820.184DHR - not or inadequately maintained
21 CFR 820.80(e)Documentation

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FDA Inspection

R.E.C. Manufacturing Corp.February 26, 2019