The FDA’s observations primarily focused on CAPA issues and record-keeping. Read More

The FDA issued a warning letter to contact lens manufacturer The See Clear Company, citing problems with its complaint and corrective action procedures. Read More

Device manufacturers operating in Australia will face more intense inspections if their CAPA plans fail to satisfy the Therapeutic Goods Administration after three tries following an inspection. Read More

The FDA cited device manufacturer US Vascular for a wide range of deficiencies, including inadequate procedures for handling complaints. Read More

Simply being FDA compliant — even if you’re following every regulation as closely as it can be followed — may not be enough to make your medical device one of high quality, and it is high quality devices that will not result in recalls or adverse events. Read More

The FDA cited device manufacturer Medtronic for lack of corrective action procedures and inadequate handling of complaints. Read More

The FDA issued warnings to three device manufacturers for failures in GMPs, validations, MDRs, and other quality-related areas. Read More

The agency found the company’s response to a Form 483 to be inadequate. Read More

Epimed International Inc. was cited in a Form 483 for inadequate procedures for handling of complaints, design validation, design transfer, control over products, services and suppliers, and accepting incoming products at its Johnstown, N.Y. facility. Read More