Rubicon CEO Office
Compliance Monitor
FDA, quality, and facility risk — the risk-compression layer
Facility riskFacility riskOne card per site. The status badge (solid ink = Red / highest risk, outline = Amber, light = Green) and the inspection-readiness score (0–100) summarize quality health; the metrics below — open deviations, overdue CAPAs and audits — explain the rating. Emphasized values are the ones over threshold.
Six manufacturing & R&D sites
Ambernath Oral Solids
Ambernath, Maharashtra
Inspection readiness
88
- Last inspection
- 2025-06-14
- Outcome
- NAI
- Open deviations
- 4
- CAPA overdue
- 1
- Supplier audits overdue
- 0
- Utilization
- 84%
Oral SolidsER/SprinkleHigh-potency containment
Ambernath Nasal
Ambernath, Maharashtra
Inspection readiness
71
- Last inspection
- 2024-11-09
- Outcome
- VAI
- Open deviations
- 9
- CAPA overdue
- 3
- Supplier audits overdue
- 2
- Utilization
- 79%
Nasal SpraysMetered DoseDrug-Device Combination
Satara Oral Liquids
Satara, Maharashtra
Inspection readiness
90
- Last inspection
- 2025-09-22
- Outcome
- NAI
- Open deviations
- 3
- CAPA overdue
- 0
- Supplier audits overdue
- 1
- Utilization
- 73%
Oral LiquidsSuspensionsSolutions
Pithampur
Pithampur, Madhya Pradesh
Inspection readiness
58
- Last inspection
- 2024-08-30
- Outcome
- OAI
- Open deviations
- 14
- CAPA overdue
- 6
- Supplier audits overdue
- 3
- Utilization
- 68%
TopicalsCreamsGelsOintments
Canada R&D
Mississauga, Ontario
Inspection readiness
93
- Last inspection
- 2025-05-05
- Outcome
- NAI
- Open deviations
- 1
- CAPA overdue
- 0
- Supplier audits overdue
- 0
- Utilization
- 71%
Formulation R&DAnalyticalOphthalmic dev
Thane R&D
Thane, Maharashtra
Inspection readiness
77
- Last inspection
- 2025-02-11
- Outcome
- VAI
- Open deviations
- 6
- CAPA overdue
- 2
- Supplier audits overdue
- 1
- Utilization
- 76%
Formulation R&DPilot scale-upStability
Compliance heatmapCompliance heatmapA grid of every facility against every quality dimension. Scores run 0–100; darker cells flag greater risk so weak spots jump out. Read across a row to judge a site, down a column to judge a process across the network.
Quality health across dimensions (0–100, higher is better)
| Facility | SOP Review | CAPA Aging | Deviations | Supplier Audits | Training | Batch Failures | Inspection Ready |
|---|---|---|---|---|---|---|---|
| Ambernath Oral Solids | 90 | 86 | 82 | 92 | 88 | 90 | 88 |
| Ambernath Nasal | 74 | 62 | 58 | 60 | 78 | 66 | 71 |
| Satara Oral Liquids | 92 | 94 | 88 | 84 | 90 | 92 | 90 |
| Pithampur | 60 | 44 | 48 | 52 | 64 | 56 | 58 |
| Canada R&D | 94 | 96 | 94 | 90 | 92 | 95 | 93 |
| Thane R&D | 80 | 70 | 72 | 74 | 82 | 78 | 77 |
Healthy (80+) Watch (65–79) At risk (<65)
AI quality summaryAI quality summaryThe copilot reads the facility and heatmap data and writes the quality story in words: the recurring risks, which sites need attention first, where supplier audits are slipping, and the questions worth asking your Quality Head.
Top recurring quality risksHow this worksPatterns the copilot sees repeating across sites and batches — the systemic issues behind the ratings, not one-off events.
- CAPA aging beyond target at Pithampur (OAI site) — 6 overdue, 12 across the network.
- Repeated deviations on nasal-spray validation batches at Ambernath Nasal driving the Amber rating.
- Topical batch-failure and SOP-review gaps at Pithampur keeping the site in Red.
Facilities requiring attentionHow this worksSites ranked to the top of the queue by inspection outcome, readiness score, and overdue CAPAs — where to spend quality-leadership time first.
Pithampur
OAI · readiness 58 · 6 CAPA overdue
Ambernath Nasal
VAI · readiness 71 · 3 CAPA overdue
Thane R&D
VAI · readiness 77 · 2 CAPA overdue
Supplier audit issuesHow this worksSuppliers whose audits are overdue. These matter most when the supplier feeds a launch-stage product, because an audit gap can hold up the launch.
Ambernath Nasal2 overdue
Satara Oral Liquids1 overdue
Pithampur3 overdue
Thane R&D1 overdue
Prioritize overdue audits for critical-API suppliers feeding launch-stage products.
Suggested CEO questions for Quality HeadHow this worksReady-to-use questions, drawn straight from the data above, to drive a sharp quality review without prep.
- 1Why are CAPAs at Pithampur aging beyond target, and what is the burn-down plan?
- 2Which supplier audits are overdue for critical APIs, and which launches do they gate?
- 3Are there repeated deviations across nasal-spray validation batches, and is root-cause closed?
Synthetic demo data. Not real Rubicon or FDA data.