Recurring oil leaks in manufacturing equipment, likely the cause of black particle contamination in 13 batches of API, led to Warning Letter 320-12-004 to Akzo Nobel Chemicals in Mexico. The letter mentions both GMP violations observed during the inspection and shortcomings in the company's reply to the inspection report.
The drugmaker failed to identify the contaminant and its cause. Operators saw the particles during the FDA's April-June visit, the letter says, and they reported a hydraulic oil leak. But no investigation followed. Akzo "assumed that the black particles are hydraulic oil contamination," without investigation or identification, the warning says.
The drugmaker dug the hole deeper in its initial response to the inspection report, replying that it repaired the equipment each time it leaked. "Your response ... fails to explain why your firm continually authorized the use of manufacturing equipment known to be defective," the warning states.
Another citation involves shortcomings in handling quarantined API. Inspectors discovered that a contaminated API lot was released and shipped to a U.S. distribution center; Akzo discovered its error and had the material returned. "However, the API was improperly identified as released while in transit, both to and from your distribution center," the letter states.
- here's Warning Letter 320-12-004
Special Report: Fierce's 2011 warning letters report