Among the warning letters posted to the FDA website on February 21, 2012 is a letter to FSC Laboratories dated June 9, 2011 detailing violations related to quality controls for the manufacture of the E-Z Spacer collapsible holding chamber for metered dose inhalers. According to the letter, a March 2011 FDA inspection found that the company “is a virtual company that specializes in the acquiring, developing, and marketing of medical devices and drugs” and that it failed to establish a quality plan or a quality agreement with the contract manufacturer.
The FDA letter also criticizes FSC for failing to address previously identified quality problems: “Your firm failed to adequately document corrective and preventive action activities and their results, as required by 21 CFR 820.100(b). For example, at least 12 complaints on the EZ Spacer have been documented since 2008 for distorted handles, difficulty in opening, and broken devices. Additionally, EZ Spacer product design and tooling quality issues have been documented by your firm. Continued quality issues have been reported and our investigator observed correspondence from your contractor, attached to each complaint reviewed, indicating the need for device design changes. Corrective and preventative measures have not been adequately addressed, documented, or implemented by your firm.”
Read the FDA warning letter to FSC.
