Lot 2026.09 · Point-in-time since 2001

Every drug has a plant. Every plant has a record.

Sourcebrook links listed drug companies to the plants that make their drugs, and to every inspection problem there.

US-listed drug companies
655
FDA drug and biologics facilities
26,911
FDA inspections since Oct 2008
66,781
Company filings read since 2001
8,055

01 / Traceability

One plant. Four listed companies.

We read which plant makes each drug from annual reports and FDA drug labels, then attach everything on record there: FDA inspections, warning letters and what companies disclosed.

  1. Company

    Geron

    GERN · CIK 0000886744

    From SEC EDGAR.

  2. Drug

    RYTELO (imetelstat)

    188 mg vials

    From the FDA drug label.

  3. Plant

    Catalent Indiana, LLC

    Bloomington, IN · FEI 3005949964

    The label: “Manufactured by (188 mg vials): Catalent Indiana, LLC”.

  4. Record

    OAI, 24 Apr 2026

    Warning letter 21 Nov 2025
    12 FDA inspections since 2013

    The plant is also named in 8-Ks by Regeneron, Scholar Rock and Incyte.

Catalent Indiana, LLC: every FDA inspection since 2013

FEI 3005949964 · 1300 S Patterson Dr, Bloomington, Indiana

Catalent Indiana, Bloomington: FDA inspections and company filings, 2013 to 2026 12 FDA inspections since 2013, one peak each, taller for more serious outcomes. 17 Jun 2013 NAI; 25 Oct 2013 VAI; 07 Nov 2014 NAI; 24 Aug 2016 VAI; 19 May 2017 VAI; 19 Jan 2018 VAI; 03 Aug 2018 NAI; 18 Oct 2019 VAI; 01 Sep 2022 VAI; 15 Nov 2023 VAI; 14 Jul 2025 OAI; 24 Apr 2026 OAI. Warning letter 21 Nov 2025. 01 Aug 2025 Regeneron 8-K: odronextamab CRL “also impacted by the Catalent Indiana LLC site inspection”; 23 Sep 2025 Scholar Rock 8-K: apitegromab CRL “solely related to observations identified at” the plant; 06 Mar 2026 Incyte 8-K: Zynyz CRL cited inspection findings at the plant. 2013 2015 2017 2019 2021 2023 Jan 2025 Jul 2025 Jan 2026 Jul 2026 Company 8-Ks naming the plantFDA inspections, peak height = outcome (NAI, VAI, OAI) 1 2 3 4 5 6
  1. 114 Jul 2025FDA inspection ends, classified OAI.
  2. 201 Aug 2025Regeneron 8-K: odronextamab CRL “also impacted by the Catalent Indiana LLC site inspection”. Filing
  3. 323 Sep 2025Scholar Rock 8-K: apitegromab CRL “solely related to observations identified at” the plant. Filing
  4. 421 Nov 2025FDA warning letter to the plant.
  5. 506 Mar 2026Incyte 8-K: Zynyz CRL cited inspection findings at the plant. Filing
  6. 624 Apr 2026FDA inspection ends, classified OAI.

02 / The gap

What the dashboard doesn't show.

FDA's public dashboard lists final classifications only and leaves out pre-approval inspections. Companies often disclose the problem first, in their own filings.

Exhibit · SEC Form 10-Q Accepted 30 Jul 2026, 16:11:33 ET

Bausch Health Companies Inc. BHC · CIK 0000885590

“In June 2026, following a routine FDA inspection of our B+L Tampa, Florida facility, as part of its findings, the FDA issued an Official Action Indicated (“OAI”) of B+L’s Tampa, Florida facility.”

Stored as

accepted_at_et
2026-07-30 16:11:33
ticker, form
BHC, 10-Q
event_type
OAI
plant_operator
filer
fda_fei
1000113778
fda_plant
Bausch & Lomb Incorporated, Tampa, FL
  1. June 2026
    FDA classifies a routine inspection OAI, its most serious outcome.
  2. 30 Jul 2026, 16:11 ET
    Bausch Health's 10-Q discloses it, after the close.
  3. 4 Sep 2026
    FDA issues a warning letter to the plant, posted on 15 Sep.
  4. Mid-Sep 2026
    FDA's dashboard still lists the plant's 2023 “No Action” inspection as its latest.
22/52

plant problems we matched in company filings since 2009 never reached FDA's dashboard.

11/16

of the problems tied to a drug under FDA review never reached it either.

03 / Specification

Certificate of analysis.

What a license contains, counted from the sources, and how often our labels were right when checked by hand.

Sourcebrook

Certificate of analysis

Plant Inspection Records

Lot
2026.09
Released
23 Sep 2026
Format
CSV + dictionary
Identifiers
Ticker, CIK, FEI
TestSpecificationResultStatus
CompaniesUS-listed drug and biologics filers655Complies
Company–plant linksPlants named in 10-Ks and FDA drug labels210 companiesComplies
FDA facilitiesDrug and biologics sites, FDA Data Dashboard26,911Complies
FDA inspectionsClassified NAI, VAI or OAI, Oct 2008 onward66,781Complies
Filings read8-K, 10-Q, 10-K and 6-K, 2001 onward8,055Complies
Disclosed statementsQuoted, time-stamped to SEC acceptance1,677Complies
EU and UK statementsGMP non-compliance, EudraGMDP and MHRA87Complies
Label precisionKept statements that were real inspection problems, checked by hand92–95 % 2019–26
80 % 2001–18
Complies
Personal dataNoneNoneComplies
Non-public informationNoneNoneComplies

Sources: SEC EDGAR, FDA Data Dashboard, openFDA, FDA warning letters, EudraGMDP, MHRA. Every record was public when dated. Plant IDs are mapped with today's FDA plant list.

210/655
companies linked to at least one FDA-registered plant today, one tablet each.

Many companies don't name their manufacturers. Where a filing names a manufacturer but not the site, every candidate site is listed and marked.

04 / Delivery

Files your team can load today.

CSV tables with a data dictionary. Each row carries the moment it became public, so the history replays as it was known.

A

Full history

Company disclosures back to 2001 and FDA inspections back to October 2008, in one file set.

B

Weekly updates

New and changed rows every week, with the same columns and identifiers: ticker, SEC CIK, FDA FEI.

C

Same-day email

OAI classifications, warning letters and company disclosures, on the day they appear.

What it isn't

Public records only No personal data No non-public information No predictions or ratings Not investment advice

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