1Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Inspection Record
McNeil Healthcare, LLC — FDA 483 Findings
Inspectors Jose R Lopez · Raquel Gonzalez RiveraThe 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
Investigations of an unexplained discrepancy did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy.
3Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
4Complaint and recall handling
An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning bacteriological contamination and significant chemical, physical, or other change or deterioration in a distributed drug product.
5Equipment and facility
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
6Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
7Laboratory and QC controls
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.
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.
