1Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of d.iug products purp01iing to be sterile are not established, written and followed.
Inspection Record
Snyder Mark Drugs Roselle, Inc. dba Mark Drugs Pharmacy — FDA 483 Findings
Inspectors Christopher D Leach · Bryan L McguckinThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Stability and storage
There is no written testing program designed to assess the stability characteristics of dmg products.
3Aseptic processing and sterility assurance
Each batch of chug product pmporting to be sterile and pyrogen-free is not laboratory tested to detennine conformance to such requirements.
4Training and personnel
Clothing of personnel engaged in the processing of dmg products is not appropriate for the duties they perform.
5Laboratory and QC controls
Each batch of chug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.
6Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
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.
