FDA Warns 14 International Medical Device Companies
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 Citations | Issue |
|---|---|
| 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 | ||
|---|---|---|
| Company | Country | Letter Date |
| Omega Laser Systems | United Kingdom | 17 February 2016 |
| Bedfont Scientific, Ltd. | United Kingdom | 4 February 2016 |
| Mooncup Ltd. | United Kingdom | 27 May 2016 |
| Helica Instruments, Ltd. | United Kingdom | 13 May 2016 |
| Implants International Ltd. | United Kingdom | 18 February 2016 |
| C World KSGnCorporation | Philippines | 18 February 2016 |
| A.R.C.O.S. Srl | Italy | 3 August 2016 |
| Novastep SAS | France | 28 July 2016 |
| F.P. Rubinstein Y Cia SRL | Argentina | 5 May 2016 |
| Aussimed Ltd. | Germany | 3 March 2016 |
| Spiegelberg Gmbh & Co. KG | Germany | 3 August 2016 |
| Shenzhen Creative Industry, Co., Ltd. | China | 15 January 2016 |
| Beyond Technology Corporation | China | 19 July 2016 |
| Master & Frank Enterprises Co., Ltd | China | 10 May 2016 |