Valley Biosystems

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Your firm failed to maintain records of trainings that your staff had received to adequately assess their competency and qualifications to perform their assigned tasks for Studies **(b)(4)**. Examples, include, but are not limited to, the following:

Passage 2

Failure of the QAU to inspect each nonclinical laboratory study at intervals adequate to assure the integrity of the study and maintain written and properly signed records of each periodic inspection. [21 CFR § 58.35(b)(3)].

Passage 3

Failure to retain all raw data, documentation, protocols, final reports, and specimens (except those specimens obtained from (b)(4)** **tests and (b)(4)****) generated as a result of a nonclinical laboratory study. [ 21 CFR § 58.190(a)].

Passage 4

Failure to include in the final report a description of all circumstances that may have affected the quality or integrity of the data for each nonclinical laboratory study. [21 CFR § 58.185(a)(9)].

Passage 5

You failed to include all data observed for Study **(b)(4)** in the final Study Report. Data that were not included in the final report include, but are not limited to:

Passage 6

Failure to adequately address this matter may lead to regulatory action. Failure to respond to this letter and to take appropriate corrective action could result in FDA taking regulatory action without further notice to you. If you believe that you have complied with the FD&C Act and FDA regulations, please include your reasoning and any supporting information for our consideration.