Glossary
Assay (Content or Potency)
A test that accurately measures the content or potency of the analyte present in a sample.
Related sections
21 CFR 211.160–211.194EU GMP Part I Chapter 6
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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We acknowledge the receipt of your assay method for medroxyprogesterone; however, you have not provided evidence to show that your (b)(4) method is equivalent or better than the compendial method established in the current USP.
FDA · FDA Warning Letter · 2023-08-08 -
For example, our investigator observed failing assay results for Phenylephrine at 3…
FDA · FDA Warning Letter · 2024-07-09 -
Your investigations into environmental monitoring (EM) excursion results and out-of- specification (OOS) assay results were inadequate.
FDA · FDA Warning Letter · 2025-06-03
