The Food and Drug Administration sent warning letters to 14 international medical device manufacturers, citing various regulatory concerns and issues.
The most common issues cited by the FDA were:
- Failure to establish and maintain adequate procedures for implementing corrective and preventative action — 11 citations
- Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit — 8 complaints
- Failure to adequately establish and maintain procedures to control product that does not conform to specified requirements — 7 complaints
- Failure to establish and maintain procedures to ensure that all purchased or otherwise received products and services conform to specified requirements — 6 complaints
Here are the 14 device manufacturers that received warning letters:
- Omega Laser Systems — United Kingdom
- Bedfont Scientific Ltd. — United Kingdom
- Mooncup Ltd. — United Kingdom
- Helica Instruments Ltd. — United Kingdom
- Implants International Ltd. — United Kingdom
- C World KSGnCorporation — Philippines
- A.R.C.O.S. Srl — Italy
- Novastep SAS — France
- F.P. Rubinstein Y Cia SRL — Argentina
- Aussimed Ltd. — Germany
- Spiegelberg Gmbh & Co. KG — Germany
- Shenzhen Creative Industry Co. Ltd. — China
- Beyond Technology Corporation — China
- Master & Frank Enterprises Co. Ltd — China
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