Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Your firm failed to provide adequate oversight and ensure the reliability of data related to the quality of finished drug products manufactured at your facility. Your quality assurance (QA) department was not exercising its basic responsibilities for the oversight and control over the adequacy and reliability of all CGMP data at your facility. In addition, your QA department is responsible for ensuring your employees understand and adhere to data integrity principles.
Passage 2Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)).
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 210
- 21 CFR 211.22
- 21 CFR 211.188
- 21 CFR 211.194(a)
- 21 CFR 211.68(b)
- 21 CFR 211.67(a)