1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.
Inspection Record
SCA Pharmaceuticals, LLC — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Training and personnel
Clothing ofpersonnel engaged in the manufacturing and processing ofdrug products is not appropriate for the duties they perform.
3Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile do not include adequate validation ofthe sterilization process.
4Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions.
5Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been a!Jeady distributed.
6Laboratory and QC controls
Testing and release ofdrug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release.
7Labeling and packaging
The labels of your firm's drug products do not always contain information required in section 503B(a)(10) ofthe Act.
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.
