Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Failure of testing facility management to assure a properly functioning QAU that reports deviations from protocols and standard operating procedures (SOPs) and initiates immediate corrective actions creates the potential for a high level of variability and inaccuracy that does not ensure the validity, quality, and integrity of the data.
Passage 2Failure of the Quality Assurance Unit (QAU) to fulfill responsibilities [21 CFR 58.35(b)(5), 58.35(b)(6), and 58.35(b)(3)].
Passage 3Failure to ensure that each individual engaged in the conduct of or responsible for the supervision of a nonclinical laboratory study have the education, training, and experience, or combination thereof, to enable that individual to perform the assigned functions [21 CFR Part 58.29(a)(b)]
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 58.35
- 21 CFR 58.33(a)
- 21 CFR 58.31(c)
- 21 CFR 58.35(b)(5)
- 21 CFR 58.29(a)(b)
- 21 CFR 58.81(a)(b)
- 21 CFR 58.185(a)(9)
- 21 CFR 58.90(b)
- 21 CFR 58.202