Yet another inspection by the Food and Drug Administration underscores the difficulties that Pfizer (PFE) is having with a key plant that has been responsible for severe shortages of injectables and other drugs.
The problems at the McPherson, Kan., facility, which Pfizer inherited as part of its $16 billion acquisition of Hospira three years ago, include employees who lack training to manufacture, process, or package products; a failure to review unexplained discrepancies in batches of medicines; and inadequate procedures to prevent contamination, according to an agency inspection report last July and August and posted on the FDA web site on Thursday.
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