1Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
Inspection Record
Wedgewood Connect, LLC — FDA 483 Findings
Inspectors Jolanna A Norton · Matthew R ClabeauxThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Process validation
Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
3Stability and storage
The written stability program does not assure testing of the drug product in the same container-closure system as that in which the drug product is marketed.
4Aseptic processing and sterility assurance
A septic processing areas are deficient regarding the system for monitoring environmental conditions.
5Training and personnel
Employees are not given training in the particular operations they perform as part of their function.
About this record
Extracted automatically from the document US FDA published on 2025-08-08. 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.
