1Aseptic 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 and sterilization process.
Inspection Record
Hospira Inc — FDA 483 Findings
Inspectors Jazmine N Still · Scott A GolladayThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Documentation and records
Master production and control records lack complete manufacturing and control instructions and precautions to be followed.
3Process validation
Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
4Quality unit oversight
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to assure that batches of drug products meet each appropriate specification and appropriate statistical quality control criteria as a condition for their approval and release.
5Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not fully followed.
6Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
7Deviation, CAPA, and investigation
Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up.
8Contamination control
Adequate exhaust systems or other systems to control contaminants are lacking in areas where air contamination occurs during production.
9Material and supplier control
Your examination and testing of samples did not assure that the drug product and in-process material conformed to specifications.
About this record
Extracted automatically from the document US FDA published on 2021-05-05. 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.
