Warning Letter 11-PHI-05, to Hawkeye-Jensen CEO Wendy Shartle, contains reminders of repeat violations stretching back more than a decade. Among them: a failure to validate the manufacturing processes used to produce a wound-healing cream.
"This is a repeat observation from the September 2000 inspection," the letter says.
Likewise, H-J failed to validate the cleaning process for a filling machine used to manufacture ear drops and baby lotion. "We are concerned about the length of time your firm has needed to develop and implement cleaning validation plans, despite your awareness of our concerns since the February 2006 inspection," the warning says.