Preservation Solutions, Inc. – FDA Inspection, Aug 31, 2015

Record Details

This FDA Inspection record concerns Preservation Solutions, Inc., with an inspection on August 31, 2015, issued by the Center for Devices and Radiological Health, covering devices.

Company: Preservation Solutions, Inc.
Inspection Date: August 31, 2015
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · b9de6f7f-0bfb-4589-8f95-17ddd8c277f4

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 977042
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 820.75(a)Lack of or inadequate process validation
21 CFR 820.75(c)Process changes - review, evaluation and revalidation
21 CFR 820.30(d)Design output - documentation
21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
21 CFR 820.86Acceptance status

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Other FDA inspections of Preservation Solutions, Inc.

Date	Classification	Office	Project area
June 6, 2025	OAI	Center for Devices and Radiological Health	Compliance: Devices
July 14, 2023	OAI	Center for Devices and Radiological Health	Compliance: Devices
September 30, 2021	OAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
March 12, 2019	OAI	Center for Devices and Radiological Health	Compliance: Devices
August 10, 2018	VAI	Center for Devices and Radiological Health	Compliance: Devices