Glossary
Batch Number (or Lot Number)
A distinctive combination of numbers, letters, or both that uniquely identifies a batch and allows its manufacturing and distribution history to be traced.
Source · MFDS, 「알기 쉬운 GMP 용어집」, Batch Number (or Lot Number) Korean original
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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Some of your facility’s drug products did not include the following statements on the label: “This is a compounded drug,” “not for resale,” the date of compounding, and the lot or batch number.
FDA · FDA Warning Letter · 2021-11-09 -
Upon further review of your records and information, it appears that you assign the same batch number to different products fulfilled on a single Purchase Order.
FDA · FDA Warning Letter · 2026-10-13 -
(b) The batch number of the vehicle was incorrectly documented as the lot number on formulation sheets.
FDA · FDA Warning Letter · 2023-10-31
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
MFDS, 「알기 쉬운 GMP 용어집」, Batch Number (or Lot Number) Korean originalGRM Regulatory Glossary
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