Glossary
Specification
The set of tests, analytical procedures, and acceptance criteria against which a material is judged suitable for its intended use.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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Your firm did not have adequate stability data to demonstrate that the chemical and microbiological properties of your drug products met established specifications and remain acceptable throughout their…
FDA · FDA Warning Letter · 2024-08-13 -
You have not established scientifically sound and appropriate specifications and test procedures to assure that VBM, CFM/EFM, and OVM conform to appropriate standards of identity, strength, quality, and…
FDA · FDA Warning Letter · 2024-08-27 -
Additionally, you failed to ensure that adequate specifications were established for the drug products, (b)(4) and (b)(4) Ointment, you manufacture and to ensure each batch was tested for, and conformed to, all…
FDA · FDA Warning Letter · 2024-10-01
