Surface plants that have closed two or more FDA inspections as OAI. The structural-risk cohort underneath the warning-letter and import-alert feeds.
47 plants carry two or more OAI inspection closures across the FDA cycle. Sun Pharma Halol leads the international list with five OAI cycles, last closed June 2025; Gland Chemicals Kanchipuram closed its fourth OAI in November 2025. The list is a structural-risk cohort: any single OAI is a stress event, but repeats signal patterns that did not close after the prior CAPA. PharmaDB joins repeat-OAI status to active warning-letter and import-alert chips at the same plant.
Default is 2+ OAI inspections at the same plant. Toggle to 3+ for the deeper structural-risk cohort, or filter by country and trailing window.
Every plant meeting the threshold with its OAI count, last OAI date, cumulative 483 observations, and active enforcement chip (warning letter, import alert).
Citation-anchored dossier per plant with the OAI cycle history, observation trajectory, and a recommendation tier (block, watch, qualifiable with conditions).
A single OAI is an event; two or more is a pattern. The list isolates plants where the CAPA after the prior OAI did not hold.
Deteriorating (each cycle worse), flat (same severity), or recovering (improving toward VAI / NAI). Powers the qualification recommendation tier.
Repeat-OAI plants with an active warning letter or import alert get a stack-rank chip. The combination is the highest-severity supplier risk.
New OAI closures move plants onto the list as the FDA publishes. Recoveries move plants off when a follow-up NAI cycle clears.
A real chat thread in PharmaDB. Type a question, the AI agent runs the tools, the answer lands as a saveable note.
pharmagraph_query Twelve plants from the repeat-OAI cohort · OAI cycle count and trajectory shown · live warehouse.
The repeat-OAI list is the structural-risk cohort underneath the warning-letter and import-alert feeds. PharmaDB groups inspections by plant, ranks by OAI count, and overlays active enforcement. The view is inspections filtered to classification = 'OAI'; the aggregation is at the plant level. Refresh cadence is weekly.
A single OAI cycle indicates a stress event that may close with a successful CAPA. Two or more OAI closures, especially within five years, indicate the CAPA did not hold. The structural pattern is the signal: management, systems, or culture failed to absorb the prior finding.
Total number of FDA inspections closed at the plant with classification OAI, across the full catalog. The headline list uses a 2+ threshold; the 3+ list is the deeper structural-risk inner ring.
The OAI count is cumulative, so the plant remains on the list. The trajectory chip flips to recovering if a follow-up NAI cycle closes; the recommendation tier moves from block to qualifiable-with-conditions on a clean cycle.
EMA non-compliance reports and EDQM CEP suspensions are tracked separately. The companion view joins multi-regulator outcomes to the same plant entity, so a plant carrying an EMA non-compliance plus an FDA OAI surfaces with a stack-rank chip.
The FDA inspection feed is pulled weekly. New OAI closures publish on a two-to-four-month delay from the cycle close; PharmaDB surfaces each as the FDA publishes. The catalog row carries the publication date and the as-of timestamp.
US compounders and OTC manufacturers form roughly 60% of the repeat-OAI cohort by count, driven by section 503A and 503B oversight density. API and fill-finish plants form the remainder and matter more to a generics buyer. The brief notes the FDA programme so a buyer can filter accordingly.
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.