Track every FDA warning letter, untitled letter, and import alert issued to pharmaceutical plants. Joined to your supplier base and refreshed weekly.
The FDA has issued 172 pharmaceutical warning letters in the catalog, with a further 341 active import alerts. The trailing 60-day feed below shows the most recent eight, drawn from the live `compliance_events` table. Adulterated CGMP findings on finished pharmaceuticals dominate; an active Indian API site (Flowchem) was added on 2026-03-11.
Upload or define your supplier base. PharmaDB resolves each supplier to its plant entities.
Every FDA warning letter, untitled letter, and import alert is matched against the resolved plant list weekly. New matches surface as notifications.
Each match becomes a citation-anchored brief with the letter date, the issuing programme, and a plain-English summary of the cited violations.
Every FDA enforcement event resolved to the plant entity. Match to your supplier list and get notified on new findings.
Warning letter, untitled letter, and import alert are distinct enforcement tools. The feed labels each so the response can match the severity.
Historical median time-to-resolution per plant is computed across the catalog. A warning letter resolves on average in roughly seven months; deviations from that get flagged.
Catalog refreshes weekly. New letters appear within days of FDA publication; the brief carries the publication date and the URL of the official FDA letter.
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pharmagraph_query Twelve plants with at least one active enforcement event in the catalog · plant location and current inspection-class consequence shown.
The warning-letter monitor is the continuous compliance signal on top of the 483 feed. PharmaDB joins enforcement events to the plant catalog, resolves them to a buyer’s supplier list, and surfaces matches as the FDA publishes. The view is compliance_events; the join is to plants. Refresh cadence is weekly.
A warning letter is the FDA's strongest pre-litigation enforcement tool — it cites specific violations and demands corrective action. An untitled letter is less severe and used for issues that don't warrant a warning letter. An import alert (66-40 / 66-41 / others) directs FDA field staff to detain products at the border without inspection. All three are tracked separately.
The FDA publishes warning letters on its public site after a several-week internal review. PharmaDB pulls the publication feed weekly, so a published letter typically appears within seven days of FDA publication. The catalog row carries both the issue date and the publication date.
Until the plant successfully petitions for removal. The catalog tracks the active import-alert list; when a plant is delisted, its status flips to inactive on the next refresh. Historical median active time is roughly two years across the dataset, but the variance is wide.
Median time from a warning letter to a subsequent NAI inspection at the same plant, across the entire historical dataset, is roughly 223 days. PharmaDB surfaces it as an empirical reserve-sizing input — useful for finance modeling supply risk and for BD timing on distressed-asset conversations.
The companion analysis covers EMA non-compliance reports, MHRA inspection failures, EDQM CEP suspensions, and WHO PQ withdrawals. Cross-regulator enforcement views surface as a separate compliance dossier.
Yes — the source taxonomy is the FDA's. CGMP letters issued to compounding pharmacies, OTC manufacturers, and contract manufacturers all surface. The brief notes the FDA programme so a buyer can filter to API-relevant matches.
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