www.fdanews.com/articles/189098-hospiras-rocky-mount-facility-cited-for-qs-failures
Hospira’s Rocky Mount Facility Cited for QS Failures
November 8, 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.