Steiner Biotechnology LLC – FDA Inspection, Dec 13, 2018

Record Details

This FDA Inspection record concerns Steiner Biotechnology LLC, with an inspection on December 13, 2018, issued by the Center for Devices and Radiological Health, covering devices.

Company: Steiner Biotechnology LLC
Inspection Date: December 13, 2018
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: Janet Pulver (FDA Associated Person)

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ID · e49e1e03-57c4-4e15-981f-2feca0ee3eb2

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1074875
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 820.120Lack of or inadequate procedures for labeling
21 CFR 820.184Lack of or inadequate DHR procedures
21 CFR 820.198(a)Lack of or inadequate complaint procedures
21 CFR 820.198(c)Investigation of device failures
21 CFR 820.20(c)Management review - Lack of or inadequate procedures
21 CFR 820.22Quality audits - Lack of or inadequate procedures
21 CFR 820.30(a)Design control - no procedures
21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
21 CFR 820.75(a)Lack of or inadequate process validation

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Other FDA inspections of Steiner Biotechnology LLC

Date	Classification	Office	Project area
February 14, 2025	Not classified	San Francisco District Office	Compliance: Medical Devices
January 16, 2025	VAI	San Francisco District Office	Product Evaluation: Medical Devices
February 1, 2024	Not classified	San Francisco District Office	Compliance: Devices
November 8, 2022	OAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
August 19, 2022	OAI	Center for Devices and Radiological Health	Compliance: Devices