A variety of problems led to an FDA import alert against an AkzoNobel plant near Mexico City, including not checking black particles in batches of products where hydraulic oil had been discovered leaking.
But a year after the inspection that cited problems at the plant owned by the Dutch conglomerate, the FDA has said it is now operating properly. The agency recently posted the June 11 closeout letter.
When the plant was inspected in June 2011, inspectors cited the plant for failing to properly get to the root cause of the black particles found in some product. But that was not the only problem. The company also was cited for an ineffective material handling process that allowed a contaminated API lot to slip through and get shipped to a distribution center in the U.S. It was recalled before it was distributed, but the FDA criticized the company for not having quarantined product sufficiently identified to keep it from nearly being released to drugmakers.
Inspectors were also unimpressed during the June 2011 inspection with maintenance at the AkzoNobel plant, saying it continued to use equipment that had been leaking hydraulic oil, which had to be tied to a trend of oil-contaminated product. All of that led to November 2011 warning letter laying out the problems and publicizing the alert that kept product from coming into the U.S.
But all of that has been resolved. The closeout letter says inspectors will see if the improved operations continue, but for now, "it appears that you have addressed the violation(s) contained," in the warning letter.
The FDA is slated to get more money for foreign plant inspections, but has undertaken a number of programs to stretch resources, such as delineating when it will accept inspections from some other countries in place of doing its own.
- read the warning letter
- read the closeout letter
- get the in-Pharma Technologist story