DEVICE FIRM WARNED ABOUT PROCEDURAL LAPSES
Skytron violated current good manufacturing practices and lacked adequate standards for complaint reviews, making its surgical beds adulterated and misbranded, an FDA warning letter said.
During inspections July 11-12, 2006, an FDA investigator found several problems, said the Nov. 29 letter, posted recently to the FDA website.
The company did not complete required inspections, resulting in a failure to detect that some of its surgical tables were missing gravity stoppers before distributing them. This resulted in a recall, the warning letter said.
Skytron did not have an adequate standard procedure for complaint reviews, and did not keep consistent records of complaint evaluations and investigations. Specifically, the company did not determine whether events merited reporting to the FDA or whether investigations were necessary, the letter said.
The warning letter can be viewed at www.fda.gov/foi/warning_letters/g6153d.htm (http://www.fda.gov/foi/warning_letters/g6153d.htm).