Compliance Requirements

21 CFR Part 117.139 - Recall Plan

21 CFR Part 211.150 - Distribution Procedures
- Recall Plan must be written
- Recall Plan must have written procedures (SOPs)
- Recall Plan must include managing recalled materials
- Recall Plan must include disposing of recalled materials
- Recall Plan must include notifying the public
- Recall Plan must include conducting effectiveness checks (recall exercises during working hours and non-working hours)
- Recall Plan must include disposition of recalled materials (reprocessing, reworking, diversion of use, or destruction)
Arnel Ryan
FS, PCQI, FSVPQI, FSQA
1-703-906-9719
arnel@consultareinc.com

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