FDA Warns 14 International Medical Device Companies

Posted 16 August 2016 By Michael Mezher


The US Food and Drug Administration (FDA) has released a slew of warning letters—14 in total—sent from the Center for Devices and Radiological Health's (CDRH) Office of Compliance to five device manufacturers located in the UK, three in China, two in Germany, and one each in Argentina, France, Italy and the Philippines.

By far the most common issues cited by FDA were:

Number of CitationsIssue
11 Failure to establish and maintain adequate procedures for implementing corrective and preventative action (CAPA), as required by 21 CFR 820.100(a)
8 Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a)
7 Failure to adequately establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a)
6 Failure to establish and maintain procedures to ensure that all purchased or otherwise received products and services conform to specified requirements, as required by CFR 820.50

Additionally, nearly all of the warning letters (11 out of 14) cited the recipient for violating a subsection of 21 CFR 820.30, which requires manufacturers to establish and maintain procedures related to device design.

Medical device reporting was also cited as an issue in five of the warning letters, with FDA saying the companies failed to develop, maintain and implement medical device reporting requirements.

In four of the 14 warning letters, FDA says it did not review all or part of the companies' responses to their respective inspection observations because they were sent after the 15-day window in which FDA requires a response.

FDA Warning Letters to International Device Makers
CompanyCountryLetter Date
Omega Laser SystemsUnited Kingdom17 February 2016
Bedfont Scientific, Ltd.United Kingdom4 February 2016
Mooncup Ltd.United Kingdom27 May 2016
Helica Instruments, Ltd.United Kingdom13 May 2016
Implants International Ltd.United Kingdom18 February 2016
C World KSGnCorporationPhilippines18 February 2016
A.R.C.O.S. SrlItaly3 August 2016
Novastep SASFrance28 July 2016
F.P. Rubinstein Y Cia SRLArgentina5 May 2016
Aussimed Ltd.                   Germany3 March 2016
Spiegelberg Gmbh & Co. KGGermany3 August 2016
Shenzhen Creative Industry, Co., Ltd.China15 January 2016
Beyond Technology CorporationChina19 July 2016
Master & Frank Enterprises Co., LtdChina10 May 2016

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Categories: Medical Devices, News, US, Europe, China, Latin America and Caribbean, CDRH

Tags: Quality System Regulation, Medical Device Reporting, Corrective and Preventative Action, CAPA, Warning Letter

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