1Complaint and recall handling
Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.
Inspection Record
McNeil Consumer Healthcare Inc. — FDA 483 Findings
Inspectors Anita R. Michael · Joseph L. Despins · Temar Q. Williams and 1 moreThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy and the failure ofa batch or any of its components to meet any ofits specifications whether or not the batch has been already distributed.
3Process validation
Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in - process material and the drug product .
4Deviation, CAPA, and investigation
Investigations of an unexplained discrepancy and a failure of a batch or any of its components to meet any of its specifications did not extend to other batches ofthe same drug product and other drug products that may have been associated with the specific failure or discrepancy.
5Deviation, CAPA, and investigation
Written records are not always made of investigations into unexplained discrepancies.
6Quality unit oversight
Records are not maintained so that data therein can be reviewed at least annually to evaluate the quality standards of each drug product to determine the need for changes in specifications or manufacturing or control procedures.
7Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not fully followed.
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.
