1Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile are not established and written.
Inspection Record
Hospira Boulder, Inc. — FDA 483 Findings
Inspectors Tara L Breckenridge · Richard L. Rutherford · Michele L. ObertThe 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
Establishment ofthe reliability of the container supplier's report of analyses is deficient in that the test results are no t appropriately validated at appropriate intervals.
3Other quality system
Test devices are deficient in that instruments, apparatus, gauges, and recording devices not meeting established specifications are used.
4Aseptic processing and sterility assurance
Adequate exhaust systems or other systems to control contaminants are lacking in areas where air contamination occurs during production Specifically, Smoke studies are not representative of actual production practices which assess whether or not appropriate air changes and laminar air flow exists and can be maintained in a Grade A filling area.
5Process validation
There are no written procedures for production and process controls designed to assure that the drug products have the i dentity, strength, quality, and purity they purport or are represented to possess.
6Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that drug products conform to appropriate standards ofidentity, strength, quality and purity.
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.
