The list of plants with a recent OAI inspection that remain commercially active. Joined to your supplier base, refreshed weekly, citation-anchored.
666 commercially active plants carry at least one OAI inspection closure in the catalog. The list is the working supplier-risk inventory: plants that have not lost their authorisation but have failed at least one cycle. The top of the ranking is dominated by US compounders and a smaller cohort of Indian fill-finish and API sites with multiple cycles. Each row carries the most-recent OAI date, the cumulative observation count, and the active enforcement chip.
| # | Plant | Region | OAI cycles | Last OAI date | Active enforcement |
|---|---|---|---|---|---|
| 1 | Belleview Biosciences | US · Brooksville | 6 OAI cycles | Mar 2024 | OAI |
| 2 | Sun Pharma Halol | IN · Gujarat | 5 OAI cycles | Jun 2025 | OAI |
| 3 | Apotex Inc. | CA · Ontario | 5 OAI cycles | May 2025 | OAI |
| 4 | US Specialty Formulations | US · Allentown | 5 OAI cycles | Jul 2024 | OAI |
| 5 | Nephron SC | US · West Columbia | 5 OAI cycles | Feb 2024 | OAI |
| 6 | Iso-Tex Diagnostics | US · Alvin | 4 OAI cycles | Feb 2026 | OAI |
| 7 | Gland Chemicals Kanchipuram | IN · Tamil Nadu | 4 OAI cycles | Nov 2025 | OAI |
| 8 | Somerset Therapeutics | IN · Bengaluru | 4 OAI cycles | Feb 2025 | OAI |
Default is 24 months from the most-recent OAI close. Adjustable to 12 or 36 months. Country and FDA programme filters available.
Plant status filtered to active, OAI history surfaced, observation counts attached. The active enforcement chip (warning letter, import alert) is overlaid.
Citation-anchored list with recommendation tier per plant. Block, watch, qualifiable-with-conditions.
Filters to plants still in commercial operation. Closed or merged sites are excluded so the list is actionable for the next RFQ.
Cumulative OAI cycles per plant. One cycle is a watch event; two or more is the structural inner ring.
Warning letter, import alert, or consent decree at the same plant surfaces as a chip. The combination is the highest-severity supplier signal.
Filterable by country and FDA programme. US compounder OAI looks different from an Indian API OAI; the brief separates the cohorts.
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pharmagraph_query Approximate active OAI plant counts by country · from the live warehouse · top thirteen jurisdictions shown.
The OAI-active list is the working supplier-risk inventory. PharmaDB joins inspections to plant status and compliance overlays, then returns the active plants with their cycle counts. The view is inspections filtered to OAI, joined to plants filtered to active status. Refresh cadence is weekly.
OAI (Official Action Indicated) means the inspection findings warrant regulatory or administrative action. A warning letter or import alert may follow; operations typically continue while the plant works through CAPA. Loss of authorisation is rare; most OAI plants remain in commercial operation.
Plant status is sourced from the FDA establishment registration feed and cross-checked against shipment activity in the trade flow view. A plant with no shipment activity in the trailing 24 months and no recent FDA registration flips to inactive.
Not automatically. The recommendation tier is block for repeat-OAI plants with a stacked warning letter or import alert. Single-cycle OAI plants are watch-chip; qualifiable with stronger CAPA evidence and a follow-up clean inspection cycle in pipeline.
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. Each row carries the cycle close date and the FDA publication date.
EMA non-compliance reports, EDQM CEP suspensions, and MHRA failures are tracked separately. The companion view joins multi-regulator outcomes to the same plant entity for a combined risk picture.
Compounders dominate the OAI-active list by count but matter little to an API sourcing decision. The brief notes the FDA programme (compounder, OTC, API, fill-finish) so a buyer can filter to the API-relevant cohort, which is smaller and concentrated in India.
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