Glossary
Record
A document or data providing evidence of an activity performed or a result obtained.
Related sections
EU GMP Part I Chapter 4 21 CFR 211.180–211.194
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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For example, • Your firm could not provide records that process performance…
FDA · FDA Warning Letter · 2024-12-17 -
Your response to our request for records and other information under section 704(a)(4) indicates that you…
FDA · FDA Warning Letter · 2021-03-16 -
Based on the records and information provided, you did not demonstrate that you adequately tested your finished drug products prior to release and distribution.
FDA · FDA Warning Letter · 2024-11-26
