1Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include validation of the sterilization process.
Inspection Record
Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy — FDA 483 Findings
Inspectors Jennifer LalamaThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Process validation
Time limits are not established when appropriate f or the completion of each production phase to assure t he quality of the drug product.
3Equipment and facility
The flow of through the building is not designed to prevent contamination.
4Contamination control
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established, written and followed.
5Aseptic processing and sterility assurance
Test procedures relative to appropriate laboratory testing for sterility and pyrogens are not written and followed.
6Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredien t prior to release.
7Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
8Material and supplier control
Each lot of a component, drug product containers and closures liable to objectionable microbiological c ontamination is deficiently subjected to microbiological tests before use.
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.
