Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).
Passage 2Your quality unit (QU) failed to have adequate oversight and procedures for your contract manufacturing organization (CMO) to ensure that they operate in compliance with CGMPs.
Passage 3Your firm’s QU failed to ensure that all drug products produced for your firm possessed appropriate quality attributes. For example, your quality agreement indicates that you establish your quality requirements and your CMO must satisfy the quality requirements. Your product is labeled as sterile. However, in your response dated March 18, 2024, you submitted specifications from your CMO for your (b)(4) product labeled as sterile, showing microbiological testing with specifications of “≤(b)(4)” for aerobic plate count.
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 211.22