COMPANY LACKS ADEQUATE TESTING FILES, WARNING LETTER SAYS
The FDA warned DreamWest Innovations for failing to establish adequate design and testing files for its rapid intubation kits, making the products adulterated.
During agency inspections Nov. 1-9, 2006, an inspector found several current good manufacturing practices violations with the manufacturing of the company's SwiftGrip rapid intubation kits, the letter said.
DreamWest responded to the agency's Form 483 Nov. 28, 2006, but the response was incomplete because it did not fully explain all the procedures being implemented to correct the problems, the letter said. The FDA will conduct a follow-up inspection of the firm, according to the Jan. 19 letter, posted recently to the agency website.
According to the FDA, DreamWest failed to:
Validate the sterilization process for its intubation kits;
Approve a device design plan;
Maintain a design history file;
Document device tests and conformance verifications;
Establish a device master record; and
Establish a complaint-handling procedure and complaint files.
The warning letter can be seen at www.fda.gov/foi/warning_letters/g6212d.pdf (http://www.fda.gov/foi/warning_letters/g6212d.pdf).