1Regulatory reporting and change control
Your outsourcing facility has not submitted a report to FDA identifying product produced during the previous s months as required by section 503B(bX2XA).
Inspection Record
US Compounding, Inc. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Process validation
Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in~process material and the drug product.
3Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equ ipment to produce aseptic conditions.
4Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.
5Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
6Stability and storage
There is no written testing program designed to assess the stability characteristics of drug products.
7Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile a re not established .
8Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release.
9Aseptic processing and sterility assurance
Equipment used in the manufacture, processing~ packing or holding of drug products is not of adequate size and suitably located to facilitate operations for its Specifically, Your firm employs a REDACTED (b)(4) water system for a REDACTED (b)(4) used for cleaning of instruments, beakers, and final containers/closures used in aseptic processes.
10Labeling and packaging
The labels of your outsourcing facility's drug products are deficient.
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.
