1Material and supplier control
Medical Device and Pharmaceutical Manufacturer Adequate quality requirements that must be met by suppliers were not established.
Inspection Record
McNeil PPC, Inc. — FDA 483 Findings
Inspectors Erin. D McCafferyThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Complaint and recall handling
Complaints involving the possible failure of a device to meet any of its specifications were not investigated where necessary.
3Process validation
Control procedures are not established which 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.
4Complaint and recall handling
Written procedures describing the handling of complaints do not include provisions for review by the quality control unit of any complaint involving the possible failure of a drug product to meet any of its specifications and a determination as to the need for an investigation of any unexplained discrepancy.
5Other quality system
Not all data from quality data sources are analyzed to identify existing and potential causes of nonconforming product and other quality problems.
6Deviation, CAPA, and investigation
The corrective and preventive action procedures addressing the investigation of the cause ofnonconformities relating to product, processes, and the quality system were not complete.
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.
