Pull every regulator's inspection record for a plant in one view. FDA, EMA, ANSM, ZLG, BPOM, MFDS, SAHPRA. Joined to compliance events.
The catalog indexes 23,714 inspection cycles across seven regulators. The FDA covers 18,639 cycles; ZLG (Germany) covers 1,945; ANSM (France) 1,481; BPOM (Indonesia) 830; MFDS (South Korea) 615; SAHPRA (South Africa) 204. A plant's compliance picture is the union of every regulator's view, and plants that ship into multiple regulated markets typically carry cycles from three to five agencies. The ranking below is by regulator-cycle volume.
| # | Regulator | Jurisdiction | Cycles indexed | Most-recent cycle | Coverage chip |
|---|---|---|---|---|---|
| 1 | FDA | US · global | 18639 cycles | weekly refresh | VAI |
| 2 | ZLG | DE · EU | 1945 cycles | weekly refresh | VAI |
| 3 | ANSM | FR · EU | 1481 cycles | weekly refresh | VAI |
| 4 | BPOM | ID · SE Asia | 830 cycles | monthly refresh | VAI |
| 5 | MFDS | KR · NE Asia | 615 cycles | monthly refresh | VAI |
| 6 | SAHPRA | ZA · Africa | 204 cycles | monthly refresh | VAI |
Type a plant name, address, or national identifier (FEI, EU site ID, KR establishment). The catalog resolves to the canonical plant entity.
Every recorded inspection cycle from every regulator, with classification, observation count, and cited findings. Reverse chronological.
Citation-anchored brief with the cross-regulator history, classification consistency, and a coverage chip showing which regulators have inspected the plant.
A plant inspected by FDA, EMA, and ANSM carries three views. The dossier merges them at the plant entity so the buyer sees the full picture, not just the FDA cycle.
Regulators sometimes disagree. A VAI from FDA and a non-compliance report from EMA at the same plant is a red flag the single-regulator view would miss.
Which regulators have inspected the plant in the last five years. A plant with FDA-only coverage may be a different qualification candidate than one with FDA plus EMA plus PMDA.
Warning letters, EMA non-compliance reports, ANSM injunctions, and EDQM suspensions all overlay on the same plant. The combined enforcement picture is the real risk view.
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pharmagraph_query Inspection cycles per regulator · the union view defines the working compliance perimeter · live warehouse.
The multi-regulator history is the global compliance dossier per plant. PharmaDB joins inspections from seven regulator feeds to the same plant entity and normalises classifications. The view is inspections grouped by plant_id and regulator. Refresh cadence varies per regulator from weekly to monthly.
A plant inspected by FDA, EMA, and PMDA has been through three independent quality reviews. A plant with FDA-only coverage has been through one. Multi-regulator coverage is itself a quality signal: agencies do not duplicate each other's findings exactly, and consistent passing across three regulators is the highest-confidence qualification.
Yes. FDA uses NAI / VAI / OAI. EMA uses non-compliance report binary. ANSM and ZLG use internal codes that map roughly to FDA equivalents. PharmaDB normalises classifications to a common scale and preserves the regulator-native code in the citation.
A VAI from FDA and a non-compliance report from EMA at the same plant typically reflects different focus areas or different inspection windows. The dossier surfaces the conflict and the time-gap; both views matter for qualification.
FDA, ZLG, and ANSM refresh weekly. BPOM, MFDS, and SAHPRA refresh monthly. EMA non-compliance reports and EDQM CEP suspensions refresh as published. The catalog row carries the per-regulator refresh date.
Yes. EU GMP certificate issuance and renewals at the plant are tracked alongside inspection cycles. The certificate validity window is part of the multi-regulator view.
Yes. Single-regulator, multi-regulator, and union views are available. Useful for a buyer whose export footprint is concentrated in one or two markets and who does not need the full union picture.
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