Hospira, Inc., A Pfizer Company – FDA 483, Aug 8, 2018

The FDA Form 483 details numerous deficiencies at a pharmaceutical manufacturing facility. A critical finding involves the failure to thoroughly review unexplained discrepancies, specifically an inadequate investigation into mold contamination in the Grade A filling area in November 2017, leading to the rejection of approximately (b)(4) batches. The investigation lacked appropriate scope, root cause identification, timely initiation, and preventive actions. Apparent dried product residue, later identified as mold, was found on lyophilization tray beds, indicating inadequate cleaning.

Further issues include inadequate investigations into approximately nine previous events of unknown foreign material/gel on HEPA filter screens, and a potential data integrity event from September 2017 involving an in-process auditor affecting numerous lots. The facility also modified validated stopper washing parameters without a documented risk assessment.

Several critical defects were observed, such as an activated Diphenhydramine Carpuject unit due to an operator inappropriately re-incorporating ejected product, with no immediate interim action taken. The facility failed to submit NDA-Field Alert Reports within three working days for a cracked needle hub defect and the mold contamination event.

Aseptic processing areas were found deficient, with inadequate validation of the aseptic process, poor smoke study practices (operator breaching first air, non-worst-case loading), and lack of scientific justification for personnel monitoring. Cleaning and disinfection systems for aseptic conditions were also deficient.

Regarding quality control, visual inspection processes were inadequate, with operator training using a (b)(