1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Inspection Record
RC Outsourcing LLC — FDA 483 Findings
Inspectors Ucheabuchic Chudi-NwankworThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Routine of equipment is not performed according to a written program designed to assure proper performance.
3Contamination control
Protective apparel is not worn as necessaiy to protect drug products from contamination.
4Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
5Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
6Equipment and facility
The flow of components, drug product containers, closures, in-process materials and drug products through the building is not designed to prevent contamination.
7Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been aheady distributed.
8Regulatory reporting and change control
Your outsourcing facility has not submitted an adverse event report to FDA in accordance with the content and format requirements established through guidance or regulation under 21 CFR 310.305 as required by section 503B(b )(5).
9Other quality system
Changes to written procedures are not drafted, reviewed and approved by the appropriate organizational unit.
10Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
About this record
Extracted automatically from the document US FDA published on 2023-02-03. 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.
