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CDMO FDA inspection lookup

Type a contract manufacturer, a site or an FEI number. See every FDA inspection outcome, warning letter and recall on file for it, by site, in seconds, with the industry's NAI, VAI and OAI split to compare against.

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Cardinal Health 200, LLC

Waukegan, IL · Devices

FDA has published 19 recalls naming Cardinal Health 200, LLC.

0InspectionsNone posted
0Warning lettersNone on file
19RecallsLatest 2026-10-14: Class II
  • 2026-10-14Class II recallPresource Packs containing Medtronic Microstream Components: Intubation Kit Catalog Numbers AN23366084 AN23366085 AN2336608H AN2336608J Intu… · DevicesClass IIRecall
  • 2026-10-07Class II recallPresource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT,GU DAVINCI , Catalog Number: PGVMDVBWU; 2) KIT,GU DAVINCI , Cata… · DevicesClass IIRecall
  • 2026-10-07Class II recallPresource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLAC; 2) KIT, G… · DevicesClass IIRecall
  • 2026-10-07Class II recallPresource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAP CHOLE , Catalog Number: PGCGLCBAC; 2) KIT, LAP CHOLE , Cata… · DevicesClass IIRecall
  • 2026-10-07Class II recallPresource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAVH , Catalog Number: PB63VHSTC · DevicesClass IIRecall
  • 2026-09-30Class II recallPresource Convenience Kits: 1) KIT, PRE OP , Catalog Number: AMN548616A; 2) KIT, NICU ADMIT NEW HAN , Catalog Number: BA1DH0116B; 3) KIT, PR… · DevicesClass IIRecall
  • 2026-09-30Class II recallPresource Convenience Kits: 1) KIT, USGPIV , Catalog Number: PVMHIVMHD; 2) KIT, USGPIV , Catalog Number: PVMHIVM14; 3) KIT, USGPIV , Catalog… · DevicesClass IIRecall
  • 2026-09-09Class II recallPresource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ASLMC CRANIOTOMY , Catalog Number: PNCGCNAUM;… · DevicesClass IIRecall

11 more records: see the company page.

Cardinal Health 414, LLC

Roseville, MN · Drugs

FDA has published 4 inspections naming Cardinal Health 414, LLC.

4InspectionsLatest 2026-07-30: No action indicated · 75% NAI, 25% VAI, 0% OAI
0Warning lettersNone on file
0RecallsNone on file

Sites: Roseville, MN (1, latest NAI) · New Orleans, LA (1, latest NAI) · Dallas, TX (1, latest NAI) · Memphis, TN (1, latest VAI)

75% of Cardinal Health 414, LLC's inspections closed with no action (NAI), against 44% of the 452 drug inspections FDA has posted with end dates since March 30, 2026 (44% NAI, 46% VAI, 10% OAI).

Cardinal Health

Pomona, CA · Drugs

FDA has published 1 inspection and 1 recall naming Cardinal Health.

1InspectionLatest 2026-05-14: No action indicated
0Warning lettersNone on file
1RecallLatest 2026-10-14: Class II

Site: Augusta, GA (1, latest NAI)

100% of Cardinal Health's inspection closed with no action (NAI), against 44% of the 452 drug inspections FDA has posted with end dates since March 30, 2026 (44% NAI, 46% VAI, 10% OAI).

  • 2026-10-14Class II recallSterile Lubricant Dry Eye Relief Eye Drops, 0.5 FL OZ (15 mL); a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.c… · DrugsClass IIRecall
  • 2026-05-14FDA inspection: NAINo action indicated · Drugs · Augusta, GANAIInspection

Know the day FDA posts the next one on Cardinal Health 200, LLC

Name the CDMOs you compete with, the sites you run and the biotechs you sell to. One email when FDA inspects, writes to or recalls from any of them, with the record linked. A free account shows every source for the last 7 days. No card.

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What you get

  • Every inspection outcome, by site. NAI, VAI or OAI, the product type and the site, from FDA's Data Dashboard, for 1,505 inspection outcomes with end dates from March 30, 2026 to October 8, 2026. A name finds every site FDA lists under it; an FEI number finds one site and the company behind it.
  • Warning letters and recalls. Each letter with its subject and issuing office; each recall with its class and product, from FDA's own listings, posted since May 20, 2025.
  • The benchmark. The company's share of no-action inspections against the share across all 1,505 inspections held (64% NAI, 33% VAI, 3% OAI), or against the inspections under the same product type when the company has one.
  • The record itself. Every row links to a page that states what FDA published and links to the agency's record.

Why CDMOs check this

Sponsors are checking you. A biotech's quality team looks up a manufacturer's FDA record before an audit, a quote and a tech transfer. This is the page they see, in the words FDA used.

Competitors change on inspection day. An OAI or a warning letter at another site is the week a sponsor starts looking for a second source. The record is public the day FDA posts it.

Your own sites, in one place. One name finds every site FDA lists under it, with the outcome of each visit, instead of one dashboard query per FEI.

What the outcomes mean

NAI
No action indicated. No objectionable conditions were found, or none that justify further action.
VAI
Voluntary action indicated. Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
OAI
Official action indicated. Regulatory or administrative action is recommended. A warning letter, an import alert or a consent decree can follow.

FDA posts a classification after its review of the inspection is complete, often months after the inspection ended. Browse all inspection classifications, warning letters and recalls held, or look a company up in the company directory.

Questions

Inspection classifications are from the FDA Data Dashboard; warning letters from FDA's listing; recalls from FDA's enforcement reports through openFDA. A record may have changed since it was read. The benchmark is a count of the records held, not a rating.

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