Palamur Biosciences Private Limited

Selected passages from the FDA letter

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

Passage 1

Failure of the study director to assure that all experimental data, including observations of unanticipated responses of the test system are accurately recorded and verified [21 CFR 58.33(b)].

Passage 2

Failure of the testing facility to have standard operating procedures in writing setting forth nonclinical laboratory study methods that management is satisfied are adequate to ensure the quality and integrity of the data generated in the course of a study. [21 CFR 58.81(a)].

Passage 3

Failure of the testing facility management to assure that personnel clearly understand the functions they are to perform [21 CFR 58.31(f)].

Passage 4

Failure of the Quality Assurance Unit (QAU) to determine that no deviations from approved protocols or SOPs were made without proper authorization and documentation [21 CFR 58.35(b)(5)].