Inspection Record

ModernaTX, Inc. — FDA 483 Findings

US FDAInspected 2023-09-21Published 2023-12-27 5 findingsEquipment and facilityCleaning validationOther quality system

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

1Equipment and facility

Equipment utilized for drug substance manufacturing are not cleaned properly prior to its usage.

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.

Other records for this company

2022-01-25 · Health Canada · 11 findings
ModernaTX, Inc. findings history — including this company's other documents US FDA documents, 2023 Go to Findings search