1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental 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
2Equipment and facility
Records are not kept for the maintenance and inspection of equipment.
3Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not fully followed.
4Quality unit oversight
Each lot of components, drug product containers and closures is not withheld from use until the lot has been sampled, tested, examined, and released by the quality control unit.
5Equipment and facility
Buildings used in th e manufacturing, processing, packing and holding of a drug product are not maintained in a good state of repair.
6Laboratory and QC controls
Established test procedures are not followed.
7Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning a nd disinfecting the room and e quipment to produce aseptic conditions.
8Laboratory and QC controls
This written stability program for drug products does not include relaibale and meaningul test methods.
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.
