The U.S. Food and Drug Administration (FDA) has once again found issues with one of medical device maker Zimmer Biomet’s plants. The agency took the British drug maker to task over the presence of metal particles in a leukemia drug and criticized fishy safety protocols at an Icelandic fishery.
An inspection of Zimmer Biomet’s Warsaw, Indiana, plant from September to November revealed some serious problems. There were 14 observations of objectionable conditions and practices at the plant, two of which were repeats from another FDA inspection in 2014.
• One of those observations concerned a sterilization process in which results couldn’t be verified by a later inspection.
• The other was about inadequately established procedures for monitoring cleaning process, according to the report.
The FDA inspectors also observed that the medical device maker hadn’t adequately set in place procedures to control environmental conditions. The plant’s water system has processed water to use in manufacturing and cleaning medical devices since 2005, but the company hasn’t adequately monitored the system’s water quality in accordance with established procedures. Work and controlled environments also weren’t maintained to make sure that clean products won’t be contaminated. The FDA also took issue with the company’s lack of adequate procedures for handling complaints.
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