1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting tbe room and equipment to produce aseptic conditions.
Inspection Record
Brookfield Prescription Center dba MD Custom Rx — FDA 483 Findings
Inspectors Sandra A. Hughes · Jasjeet K. SekhonThe 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 ofdrug products .
3Laboratory and QC controls
Testing and release ofdrug product for distribution do not include appropriate laboratory detennination ofsatisfactory confonnance to the final specifications prior to release .
4Complaint and recall handling
Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.
5Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile are not established, written, and fo llowed.
6Material and supplier control
There is a failure to thoroughly review the failure ofa batch or any ofits components to meet any of its specifications whetheror not the batch has been already distributed.
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.
