1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Inspection Record
Wedgewood Connect, LLC — FDA 483 Findings
Inspectors Jeffrey P Raimondi · Anney Lin · Andrew LeThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Labeling and packaging
The labels of your outsourcing facility's drug products do not include information required by section 503B(a)(l0)(A) ofthe Federal Food, Drug and Cosmetic Act (FD&C Act).
3Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
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.
5Deviation, CAPA, and investigation
Written records are not always made of investigations into unexplained discrepancies.
6Contamination control
The separate or defined areas and control systems necessary to prevent contamination or mix-ups are deficient.
7Training and personnel
Employees are not given training in the particular operations they perform as part of their function.
8Quality unit oversight
The quality control unit lacks the responsibility and authority to approve and reject all in process materials and drug products.
About this record
Extracted automatically from the document US FDA published on 2024-02-12. 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.
