Track every recent FDA 483 observation and inspection classification at any supplier plant. The supplier-risk filter you run before any RFQ.
Dr Reddy's Medchal-Malkajgiri plant has accumulated 32 Form 483 observations across 8 FDA inspections. Seven of the eight inspections closed as VAI (Voluntary Action Indicated) and one as NAI (No Action Indicated), placing the plant in the inspection-watch band rather than the inspection-clean cohort. The plant currently holds no warning letter or import-alert status.
Type a plant name, city, or supplier. Resolves to the canonical plant entity and its FEI (Establishment Identifier).
Every recorded inspection with classification, observation count, and the recorded summary. Reverse-chronological.
Citation-anchored brief with the inspection history, severity trajectory, and a chip showing current active enforcement (warning letter, import alert) if any.
Every recorded FDA inspection per plant, with classification and observation count. Not a summary stat — the actual history.
Improving, flat, or deteriorating across the last five cycles. A plant moving from NAI to OAI signals risk earlier than a single classification.
Warning letters, import alerts, and consent decrees surface as a chip on the plant card. If a plant is under active enforcement, you see it before you RFQ.
The FDA inspection feed is pulled weekly. New inspections trickle in over the months following the cycle; PharmaDB surfaces them as the FDA publishes.
A real chat thread in PharmaDB. Type a question, the AI agent runs the tools, the answer lands as a saveable note.
pharmagraph_query Top ten Indian plants by total 483 observations · inspection count and dominant classification, live warehouse.
The 483 feed is the historical signal of supplier compliance. PharmaDB joins inspections to observations to compliance events at the plant level, so every recorded inspection cycle is one row. The view is inspections joined to inspection_observations and compliance_events. Refresh cadence is weekly.
An FDA Form 483 is a list of observations issued by an FDA investigator at the close of an inspection. It documents conditions the investigator believes may indicate violations of FDA regulations. A 483 is not a warning letter; it is the inspector's findings and the plant's window to respond.
NAI (No Action Indicated) means no objectionable conditions. VAI (Voluntary Action Indicated) means objectionable conditions are present but the agency does not plan further administrative action. OAI (Official Action Indicated) means findings warrant regulatory or administrative action — warning letter, import alert, or consent decree.
Trajectory looks at classification across the last five inspections. NAI → NAI → VAI → OAI signals deterioration. VAI → VAI → NAI signals improvement. PharmaDB flags trajectory direction as a chip on the plant card.
Drug program (CDER) inspections are the primary coverage. Device (CDRH) and biologics (CBER) inspections are included for plants that hold authorisations across programs, but the headline is the CDER drug GMP cycle.
The FDA inspection feed is pulled weekly. New inspections publish on a delay — typically two to four months from the close-out date — and PharmaDB surfaces each as the FDA publishes. The catalog row carries an as-of timestamp.
The companion analysis covers EMA, MHRA, EDQM, and PMDA inspections per plant. The same plant entity is the join key; multi-regulator inspection histories surface in a combined view at the user's choice.
Bring the molecule, the lane, or the supplier you're sourcing this week. The AI agent runs it on PharmaDB in 30 minutes. You keep the brief.