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Hospira’s Lake Forest, Ill., manufacturing facility received an FDA Form 483 for quality system deviations related to its infusion pumps, including inadequate design validation, inadequate design change procedures and inadequate corrective and preventive action procedures. Read More
The UK’s Medicines and Healthcare products Regulatory Agency, along with other European health regulators, have suspended CE certification for all products made by Brazilian implant maker Silimed after particle contamination was discovered during a facility inspection. Read More