1Aseptic processing and sterility assurance
Equipment and tools used are not of appropriate materials for use in sterile drug production.
Inspection Record
Puget Sound Drug Corporation dba Key Compounding Pharmacy — FDA 483 Findings
Inspectors Gary C. Pecic · Lisa T. MichelThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Environmental monitoring is not adequately performed in your aseptic areas.
3Aseptic processing and sterility assurance
Aseptic practices are deficient regarding the system for maintaining a en vironment suitable for production of sterile drugs.
4Contamination control
Highly potent drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or personnel to prevent cross-contamination.
5Aseptic processing and sterility assurance
The final containers/closures used for drug products intended to be sterile have not been sterilized or depyrogenated.
6Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already di stributed.
7Equipment and facility
Inadequate pressure differentials between lower quality air rooms and higher quality air rooms were observed.
8Validation and qualification
ISO-5 classified areas were not certified under dynamic conditions.
9Aseptic processing and sterility assurance
Personnel performing aseptic operations failed to disinfect or change gloves frequently enough to prevent contamination.
About this record
Extracted automatically from the document US FDA published on 2024-01-17. 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.
