1Labeling and packaging
The labels ofyour outsourcing facility's drug products do not include information required by section 503B(a)(l0)(A).
Inspection Record
PharmaLogic CSP, Inc. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Stability and storage
Res ults ofstability testing are not used in determining expiration dates.
3Labeling and packaging
The container ofyour outsourcing facility's drug products do not include information required by section 503B(a)(lO){B).
4Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
5Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.
6Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
7Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile are not followed.
8Quality unit oversight
Each lot ofdrug product containers and closures is not withheld from use until the lot has been sampled, tested, examined, and released by the quality control unit.
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.
