The FDA showcases its long memory in Warning Letter 11-PHI-05, to Hawkeye-Jensen CEO Wendy Shartle. The missive includes repeat-violation references dating from inspections in 2000 and 2006.
The agency cites findings from an inspection last August of the Shartlesville, PA, manufacturing plant. H-J lacked cleaning process validation for a non-dedicated filling machine it uses for ear drops, jewelry cleaner, nail polish and baby lotion.
The FDA's concern is residual cross-contamination. H-J promised to validate the cleaning process based on conditions from the worst-to-clean product. But there's more to it than that: "Be advised that the test methods used during your cleaning validation activities should be appropriate (e.g., selective and sensitive) to detect residue," the warning directs.
The validation promise also contained a fatal flaw: no timeframe. And that's what triggered the FDA memory jolt. "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," says the letter.
Another validation violation concerns the manufacturing process used to make a wound-healing cream. "This is a repeat observation from the September 2000 inspection," the letter says. The FDA again criticizes the H-J response for lacking a timeframe in which it would complete the work.
- here's Warning Letter 11-PHI-05