Glossary
Quality Assurance (QA)
The total arrangement of everything that bears on ensuring a medicine has the quality required for its intended use.
Source · WHO Quality Assurance of Medicines Terminology Database, Quality assurance
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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Your Quality Assurance (QA) and production departments failed to provide adequate oversight and ensure the reliability of data related to the quality of finished drug products manufactured at your facility.
FDA · FDA Warning Letter · 2023-11-28 -
Although you stated that similar deficiencies do not exist with other operators, you provided no supporting documentation (e.g., audit reports, video reviews, or Manufacturing Quality Assurance (MQA) records) to support this claim.
FDA · FDA Warning Letter · 2026-10-06 -
The final reports for studies (b)(4) did not include the correct names of the study director and other scientists or professionals involved in the study, such as the quality assurance unit (QAU) personnel.
FDA · FDA Warning Letter · 2026-03-17
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
WHO Quality Assurance of Medicines Terminology Database, Quality assuranceGRM Regulatory Glossary
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