1Equipment and facility
Equipment utilized for drug substance manufacturing are not cleaned properly prior to its usage.
Inspection Record
ModernaTX, Inc. — FDA 483 Findings
Inspectors Thai D. TruongThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Cleaning validation
Cleaning Validation studies of non-dedicated manufacturing equipment did not include challenges with actual conditions used in routine manufacturing processes.
3Other quality system
Separate or defined areas to prevent mix-ups are deficient.
4Equipment and facility
Equipment and Facilities are not designed to minimize potential for contamination.
5Other quality system
Written procedures were not followed.
About this record
Extracted automatically from the document US FDA published on 2023-12-27. 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.
