1Material and supplier control
Your examination and testing of samples did not assure that the drug product and in-process material conformed to specifications.
Inspection Record
Hospira Inc, A Pfizer Company — FDA 483 Findings
Inspectors Rita K. Kabaso · Robert J. HamThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Material and supplier control
Certificates of testing of containers are accepted in lieu of testing without establishing the reliability of the supplier's test results through appropriate validation of the test results at appropriate intervals.
3Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
4Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
5Training and personnel
Employees engaged in the manufacture, processing, packing, holding of a drug product lack the training required to perform their assigned functions.
6Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
7Complaint and recall handling
An NDA-Field Alert Report was not submitted within1hree 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.
About this record
Extracted automatically from the document US FDA published on 2019-04-30. 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.
