Thanks to the folks in Washington, most anything having to do with the federal government is closed until further notice. That means fixtures like the Grand Canyon and the Library of Congress (LOC) are off-limits.
The lion’s share of the pre-shutdown device-related warning letters involved overseas entities. A good example comes in a September 5, 2013 letter to Vincent Medical Manufacturing Company, based in Dong Guan City, China.
FDA kicked the tires at this manufacturer of breathing circuits and sterile fluid management injection systems, and didn’t like some of what it saw. For example, Vincent’s Corrective and Prevention Action (CAPA) failed to establish and maintain a number of procedures. Vincent was also charged with failing to ensure that inspection and test procedures could be validated with a “high degree of assurance.”
FDA also chided Vincent for “failure to establish and maintain procedures to ensure that participants at each design review include representatives of all functions concerned with the design stage being reviewed.”
FDA sent an August 26 letter to Bio Focus Co., based in Uiwang, Republic of South Korea. FDA hit that firm for an inadequate CAPA program, process validation, device design validation, management of suppliers and other outside vendors, and environmental controls, among several other issues. Bio Focus manufactures Sure-Aid pregnancy tests.
In Taiwan, FDA challenged St. Shine Optical, manufacturer of contact lenses, for several shortcomings. Shortcomings cited in the August 26 warning letter include: inadequate validation reports, design control procedures, and process controls.
Earlier in August, FDA issued a warning letter to Denmark-based Dako Denmark, manufacturer of the HER2 CISH pharmaDx kit. In the August 21 letter, FDA noted that the firm closed six CAPA’s, but failed to provide any evidence that the CAPA’s were effective. FDA also hit the firm for inadequate process validation protocol, and complaint processing.
FDA returned to the U.S. with a September 20 letter to Medical Device Resource Corporation. The Livermore, California-based maker of the LS2 Aspirator, and the K Pump was issued a warning letter because it’s process validation, outside products, and other product controls were found lacking.
While medical device makers may not be overly worried about a hobbled FDA, let’s all agree that it would be nice someday to be allowed to visit the Grand Canyon and the LOC again. Those are both bi-partisan places, right?