1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.
Inspection Record
Pharmakon Long Term Care Pharmacy Inc. — FDA 483 Findings
Inspectors Robert M Barbosa · Bei Y He · Investigator Emily J OrbanThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not fully followed.
3Equipment and facility
The operations relating to the processing of penicillin are not performed in facilities separate from those used for other drug products for human use.
4Stability and storage
There is no written testing program designed to assess the stability characteristics of drug products.
5Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and e quipment to produce aseptic conditions.
6Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
7Training and personnel
Clothing of personnel engaged in the processing of drug products is no t appropriate for the duties the y perform.
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.
