Glossary
Product Complaint
Also writtenquality complaintcustomer complaint
Information raising the possibility of a defect in the quality, packaging, or labelling of a distributed medicine.
Source · PIC/S PE 009-17, Part I, Chapter 8, Complaints, Quality Defects and Product Recalls
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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A written record of each complaint is not maintained in a file designated for drug product complaints at the facility where the drug product was manufactured, processed or packed.
FDA · FDA 483 · 2024-01-17 -
A written record of each complaint is not maintained in a file designated for drug product complaints at the facility where the drug product was manufactured, processed or packed .
FDA · FDA 483 · 2024-01-17 -
Complaint procedures are deficient in that written complaint records are not maintained in a file designated for drug product complaints.
FDA · FDA 483 · 2024-01-17
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
PIC/S PE 009-17, Part I, Chapter 8, Complaints, Quality Defects and Product RecallsGRM Regulatory Glossary
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