How to Respond to FDA Form 483 Austin Weber January 5, 2015 Manufacturers must react promptly or they risk getting a Warning Letter. Read More
FDA Warns Texas Medical Device Manufacturer June 5, 2013 STAFFORD, TX—The FDA issued a warning to CooperSurgical after inspectors noted violations at the company’s assembly plant here. Read More
FDA Warns Medical Device Manufacturer October 9, 2012 WASHINGTON—The U.S. Food and Drug Administration has warned Zimmer Holdings Inc. about its practices for manufacturing and testing hip implants at an assembly plant in Puerto Rico. Read More
