The US FDA's warning letter to Pfizer Inc. about a plant in McPherson, Kan., is the clearest indication yet that the quality problems the company acquired along with Hospira Inc.'s sterile injectables and biosimilars manufacturing capacity are continuing under its banner.
The agency found that the facility manufactured sterile injectable drug products that continued to contain visible particulates despite multiple complaint investigations. The presence of the particulates “is an indication of a significant loss of control in your manufacturing process and represents a severe risk of harm to patients,” FDA said in a redacted version of the Feb. 14
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