1Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
Inspection Record
Buffalo Pharmacies Inc. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Training and personnel
Clothing of personnel engaged in the processing of drug products is no t appropriate for the duties the y perform.
3Equipment and facility
Adequate ventilation is not provided.
4Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
5Equipment and facility
Routine calibration and inspection of mechanical and electronic equipment is not performed according to a written program designed to assure proper performance.
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.
