Healthcare companies that provided an update on a Form 483, consent decree, untitled letter etc. from the FDA in the last month
| ticker | Company Name | FDA action / notice type | Affected facility / product / operation | Date / period disclosed | Summary and company response / remediation | Source | Market Cap | Subsector |
|---|---|---|---|---|---|---|---|---|
| BDX | Becton, Dickinson and Co. | Form 483s, warning letters, consent decree non-compliance letter, recalls | CareFusion 303 / Medication Management Systems’ Infusion and Dispensing quality management systems in San Diego, CA; BD Pyxis products; El Paso manufacturing facility; products including ChloraPrep and PurPrep | 2020; Dec. 2021; May 2024; Nov. 22, 2024; Oct. 2025 inspection; Apr. 30, 2026 warning letter | Disclosed a 2020 Form 483 with observations on FDA Quality System, corrections/removals, and MDR regulations; a Dec. 2021 non-compliance letter under the consent decree saying some corrective actions were adequate, some ongoing, and some inadequate; a May 2024 Form 483 covering Infusion and Dispensing QMS; a Nov. 22, 2024 warning letter for the Dispensing QMS / BD Pyxis products alleging QSR, MDR, and corrections/removals violations; and an Apr. 30, 2026 warning letter for El Paso after an Oct. 2025 inspection citing cGMP deficiencies including investigations, lab controls, cleaning/contamination control, facility design, terminal sterilization, and Quality Unit concerns. Company said it submitted comprehensive responses, undertook additional corrective actions, independent quality assessments, and certain recalls; FDA review of 2024 Form 483 responses remains ongoing, and FDA may withhold export certificates and approvals until El Paso issues are addressed. | 2026-08-0610-Q | $51.10B | Medical Instruments & Supplies |
| IART | Integra LifeSciences Holdings Corp. | Multiple Form 483s, warning letters, shipping holds, voluntary recalls | Mansfield, MA; Plainsboro, NJ; Princeton, NJ; Boston facility; products including cranial perforators, disposable cottonoid patties and strips, collagen-based products, PriMatrix, SurgiMend, Revize, TissueMend | 2018-2019; Mar. 1, 2023 inspection / May 2023 recall / Jul. 17, 2023 warning letter; Jun. & Aug. 2024 inspections / Dec. 19, 2024 warning letter | FDA issued a Dec. 19, 2024 warning letter tied to 2024 Form 483s from June/August 2024 inspections at three facilities; the warning letter said it identified no new observations beyond the 2024 Form 483s. Form 483s said certain devices were out of compliance with QSR. Company imposed shipping holds and a voluntary recall of disposable patties and strips, and submitted multiple responses and updates. Also disclosed a 2023 Form 483 after a Mar. 1, 2023 Boston inspection, followed by a May 2023 voluntary global recall and a Jul. 17, 2023 warning letter that likewise did not add new observations beyond the Form 483. Also referenced a Mar. 6, 2019 warning letter after an Oct.-Nov. 2018 inspection, again not adding new observations beyond the related Form 483. | 2026-07-2910-QJul 29, 2026Earnings Call | $1.34B | Medical Devices |
