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Medical Devices / Inspections and Audits

Hospira’s Rocky Mount Facility Cited for QS Failures

Nov. 9, 2018

A number of quality system deficiencies resulted in Hospira test devices failing to meet specifications, according to a Form 483 to the Pfizer subsidiary’s Rocky Mount, North Carolina facility following a Jan. 29 to Feb. 2 FDA inspection.

Routine inspection of mechanical equipment was not performed according to a written program designed to assure proper performance, the FDA’s four-item 483 said.

Although deviations were reported, all possible root causes were not identified to ensure that corrective actions would prevent reoccurrence, the FDA said.

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