1Validation and qualification
The approved Qualification protocor for qualifying the new and upgraded ~ compression machines is ...,' missing.
Inspection Record
McNeil Consumer Healthcare — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
Failures and deviations associated with process validation batches are not documented and investigated by Quality Assurance.
3Other quality system
There is no justification for cleaning the _ .
4Validation and qualification
Qualifications for the I ••••System are incomplete in that the Qualification Final Report was not prepared ~ a,s required by the protocol.
5Other quality system
Reconciliation records for compression batches of Motrin IB cores are unclear in that compression batches do not clearly identify what granulation and how much was utilized, including samples collected and waste.
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.
