1Deviation, CAPA, and investigation
Deviations from written test procedures are not recorded and/or justified.
Inspection Record
Hospira Inc. A Pfizer Company — FDA 483 Findings
Inspectors Sarah E. Rhoades · Robert J. Ham · Michele Perry-WilliamsThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
3Deviation, CAPA, and investigation
Written records of investigations into the failure ofa batch or any of its components to meet specifications do not always included the conclusions and follow-up.
4Complaint and recall handling
Procedures describing the handling of written and oral complaints related to drug products are deficiently written.
5Complaint and recall handling
An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning a failure of one or more distributed batches of a drug to meet the specifications established for it in the application.
6Training and personnel
Employees engaged in the manufacture and processing of a drug product lack the training required to perform their assigned functions.
7Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
8Aseptic processing and sterility assurance
Cleaning procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.
9Laboratory and QC controls
Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
10Stability and storage
Drug products are not stored under appropriate conditions of temperature so that their identity, strength, quality, and purity are not affected.
About this record
Extracted automatically from the document US FDA published on 2021-04-21. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
