Lymol Medical Corporation, Woburn, MA – FDA Inspections

Inspection records and compliance data for Lymol Medical Corporation in Woburn, Massachusetts. 6 FDA inspections on record (2 OAI), 1 warning letter, last inspected July 29, 2021.

Company Profile

This profile covers Lymol Medical Corporation based in Woburn, Massachusetts, United States.

FDA Inspection History

FDA inspections: 6
OAI: 2
VAI: 4
NAI: 0
Form 483s: 0
Warning letters: 1

First inspected July 9, 2009. Last inspected July 29, 2021.

Most cited issue areas

Approve or reject procedures or specs2 inspections
Purchasing controls, Lack of or inadequate procedures2 inspections
Training--operations, GMPs, written procedures2 inspections

FDA inspections (6)

Date	Result	FDA center(s)	Insp. #
July 29, 2021	OAI	Medical Devices & Rad Health · Compliance: Devices	1147369
February 12, 2020	OAI	Medical Devices & Rad Health · Compliance: Devices	1117620
June 24, 2016	VAI	Human Drugs, Medical Devices & Rad Health · Drug Quality Assurance	976447
December 15, 2011	VAI	Human Drugs · Postmarket Surv. and Epidemiology	759069
September 14, 2010	VAI	Human Drugs, Medical Devices & Rad Health · Compliance: Devices	680212
July 9, 2009	VAI	Human Drugs, Medical Devices & Rad Health · Compliance: Devices	596000

FDA documents

Form 483s (2)

Warning Letters (1)

Warning Letters · February 12, 2020

People (4)

Sara M. Onyango

Person

Joseph S. Matrisciano

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Lymol Medical Corporation, Woburn, MA – FDA Inspections

Inspection records and compliance data for Lymol Medical Corporation in Woburn, Massachusetts. 6 FDA inspections on record (2 OAI), 1 warning letter, last inspected July 29, 2021.

Company Profile

This profile covers Lymol Medical Corporation based in Woburn, Massachusetts, United States.

FDA Inspection History

FDA inspections: 6
OAI: 2
VAI: 4
NAI: 0
Form 483s: 0
Warning letters: 1

First inspected July 9, 2009. Last inspected July 29, 2021.

Most cited issue areas

Approve or reject procedures or specs2 inspections
Purchasing controls, Lack of or inadequate procedures2 inspections
Training--operations, GMPs, written procedures2 inspections

FDA inspections (6)

Date	Result	FDA center(s)	Insp. #
July 29, 2021	OAI	Medical Devices & Rad Health · Compliance: Devices	1147369
February 12, 2020	OAI	Medical Devices & Rad Health · Compliance: Devices	1117620
June 24, 2016	VAI	Human Drugs, Medical Devices & Rad Health · Drug Quality Assurance	976447
December 15, 2011	VAI	Human Drugs · Postmarket Surv. and Epidemiology	759069
September 14, 2010	VAI	Human Drugs, Medical Devices & Rad Health · Compliance: Devices	680212
July 9, 2009	VAI	Human Drugs, Medical Devices & Rad Health · Compliance: Devices	596000