Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Failure to follow written procedures describing the handling of all written and oral complaints regarding a drug product [21 CFR 211.198(a)].** For example, the report for consumer complaint CC-000159 related to PalinGen® Flow® indicated that the incident involved a communicable disease and required medical/surgical intervention; however, you did not report this event to FDA within 15 days, as required by your written complaint procedure.
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 1271.10(a)
- 21 CFR 1271.3(d)
- 21 CFR 1271.15
- 21 CFR 1271.10(a)(2)
- 21 CFR 1271
- 21 CFR 1271.3(c)
- 21 CFR 1271.10(a)(1)
- 21 CFR 1271.10(a)(3)
- 21 CFR 210
- 21 CFR 211.100(a)
- 21 CFR 211.166(a)
- 21 CFR 211.198(a)
- 21 CFR 312