Glossary
Quality Unit(s)
The organisational unit, independent of production, that carries out both quality assurance and quality control responsibilities.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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Your quality unit (QU) did not provide adequate oversight for the manufacture of your over the counter (OTC) drug products.
FDA · FDA Warning Letter · 2023-09-05 -
The records and information you provided did not demonstrate that you have established an adequate quality unit (QU) to oversee the quality of your drug manufacturing operations.
FDA · FDA Warning Letter · 2024-05-14 -
Your quality unit (QU) failed to provide adequate oversight of your CGMP records.
FDA · FDA Warning Letter · 2024-07-23
