Compliance & Quality
Lot holds, cGMP audits, FDA label claims, shelf-life management
Active Decisions
5
Pending Review
0
Avg Confidence
83%
Critical / High
2
Decision Queue
5 decisions| ID | Entity | Escalation | Action | |||
|---|---|---|---|---|---|---|
DEC-CQ001 | Lot Hold BH-2026-0342 — L-Leucine 3.2% Out of Spec Third-party CoA shows amino acid ratio 3.2% outside spec. Within FDA tolerance but outside internal spec. $180K at risk. | HIGH | 76% | escalated | OVERDUE | |
DEC-CQ003 | PerfectAmino Powder Clumping — 12 Customer Reports Investigate 12 reports of PerfectAmino Lemon Lime clumping (Lot BH-2026-0298). Moisture ingress vs normal variation. Amazon listing at risk. | HIGH | 72% | escalated | OVERDUE | |
DEC-CQ002 | cGMP Audit Finding — Temperature Excursion Raw Storage Temperature excursion: 78°F vs 72°F max for 4 hours. No product impact per stability data. Requires CAPA for FDA compliance. | MEDIUM | 89% | approved | OVERDUE | |
DEC-CQ004 | Multi Complete Batch — Label Potency Verification New Multi Complete batch requires third-party testing for potency claims (FDA 80-120% tolerance). 10-day testing hold. | LOW | 92% | approved | 5h 46m | |
DEC-CQ005 | Erewhon Shelf-Life Audit — 3 SKUs Near Expiry 3 SKUs approaching 6-month remaining shelf life on Erewhon shelves. Pull and replace or negotiate markdown. Brand perception risk. | LOW | 88% | approved | 5h 46m |