Lymol Medical Corporation – FDA Inspection, Sep 14, 2010

Record Details

This FDA Inspection record concerns Lymol Medical Corporation, with an inspection on September 14, 2010, issued by the Center for Devices and Radiological Health, covering devices.

Company: Lymol Medical Corporation
Inspection Date: September 14, 2010
Product Type: Devices
Office: Center for Devices and Radiological Health

View Company Profile

ID · f3b30929-5efc-4cf9-9e45-1d930e1146cf

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 680212
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 820.40Lack of procedures, or not maintained
21 CFR 211.25(a)Training--operations, GMPs, written procedures
21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
21 CFR 820.22Quality Audits - defined intervals
21 CFR 211.22(c)Approve or reject procedures or specs

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Lymol Medical Corporation

Date	Classification	Office	Project area
July 29, 2021	OAI	Center for Devices and Radiological Health	Compliance: Devices
February 12, 2020	OAI	Center for Devices and Radiological Health	Compliance: Devices
June 24, 2016	VAI	Center for Drug Evaluation and Research	Drug Quality Assurance
December 15, 2011	VAI	Center for Drug Evaluation and Research	Postmarket Surv. and Epidemiology
July 9, 2009	VAI	Center for Devices and Radiological Health	Compliance: Devices