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.
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 -
(b) The batch number of the vehicle was incorrectly documented as the lot number on formulation sheets.
FDA · FDA Warning Letter · 2023-10-31 -
You stated that there were no batch records and no batch numbers.
FDA · FDA Warning Letter · 2023-03-14
