Public directory / Facility profile

Fresenius Kabi Compounding LLC dba Fagron Sterile Services, Canton

MA · FDA-registered outsourcing facility (503B). A factual public-record profile built from FDA sources, with dates. It is not a ranking, grade, or endorsement.

What the public record shows

FDA 503B registration status

FDA 503B list ✓ (current 2026-07-14)

Fresenius Kabi Compounding LLC dba Fagron Sterile Services, Canton appears on FDA's registered outsourcing facilities list, parsed from Veritura's capture of that list (FDA list current as of 2026-07-14, captured 2026-07-17). Registration status can change between captures; the FDA page is the authoritative current source.

On our captures

On FDA's list since we began tracking captures on 2026-07-11 (tracking began 2026-07-10; we make no claim about FDA's list before our first capture). Last confirmed on our 2026-07-17 capture (FDA list current as of 2026-07-14).

Dates are Veritura's own capture dates of FDA's public list, shown next to FDA's list-current date wherever we have it. Public-record posture, not a determination.

FDA enforcement timeline

10 dated enforcement records matched this firm name in openFDA when this check last completed.

  • 2026-02-05 · drug · Class II · Ongoing
    Lack of Assurance of Sterility
  • 2026-02-05 · drug · Class II · Ongoing
    Lack of Assurance of Sterility
  • 2026-02-05 · drug · Class II · Ongoing
    Lack of Assurance of Sterility
  • 2026-02-05 · drug · Class II · Ongoing
    Lack of Assurance of Sterility
  • 2026-02-05 · drug · Class II · Ongoing
    Lack of Assurance of Sterility
  • 2024-09-25 · drug · Class II · Terminated
    cGMP violations
  • 2024-09-25 · drug · Class II · Terminated
    cGMP violations
  • 2024-09-25 · drug · Class II · Terminated
    cGMP violations
  • 2024-09-25 · drug · Class II · Terminated
    cGMP violations
  • 2024-09-25 · drug · Class II · Terminated
    cGMP violations

Source: openFDA enforcement records (drug/device/food, updated weekly), checked 2026-07-18. Dated public records matching this firm name; similar firm names collide in public records, so confirm the firm identity against the source records before relying. Public-record posture, not a determination.

Live FDA enforcement screen

10 enforcement record matches on this firm name in openFDA when this screen last ran. Review the underlying public records and confirm the firm identity before relying on this signal.

0 FDA compliance action records matched this name.

Source: openFDA enforcement records and FDA compliance dashboards, refreshed at most every 6 hours. A count here documents what public sources returned for this name (searched: Fresenius Kabi Compounding LLC dba Fagron Sterile Services, Canton); it is not a Veritura determination about the facility.

Reported products

36 distinct products as reported to FDA in 503B product reports (data vintage: reporting periods 2025-2, 2025-1); 20 shown.

  • Acyclovir Sodium · 200 mg/100 mL · injection · reported period 2025-2
  • Atropine Sulfate · .4 mg/1 mL · injection · reported period 2025-2
  • Ephedrine Sulfate · 15 mg/3 mL · injection · reported period 2025-2
  • Epinephrine · 8 mg/250 mL · injection, solution · reported period 2025-2
  • Glycopyrrolate · .6 mg/3 mL · injection · reported period 2025-2
  • Ketamine Hydrochloride · 1000 mg/100 mL · injection · reported period 2025-2
  • Ketamine Hydrochloride · 50 mg/5 mL · injection · reported period 2025-2
  • Labetalol Hydrochloride · 20 mg/4 mL · injection · reported period 2025-2
  • Lidocaine Hydrochloride · 100 mg/5 mL · injection · reported period 2025-2
  • Norepinephrine Bitartrate · 8 mg/250 mL · injection, solution · reported period 2025-2
  • Norepinephrine Bitartrate · 4 mg/250 mL · injection, solution · reported period 2025-2
  • Norepinephrine Bitartrate · 32 mg/250 mL · injection, solution · reported period 2025-2
  • Oxytocin · 30 U/500 mL · injection, solution · reported period 2025-2
  • Phenylephrine Hydrochloride · 10 mg/250 mL · injection, solution · reported period 2025-2
  • Phenylephrine Hydrochloride · 1 mg/10 mL · injection · reported period 2025-2
  • Phenylephrine Hydrochloride · 80 mg/250 mL · injection, solution · reported period 2025-2
  • Phenylephrine Hydrochloride · 400 ug/5 mL · injection · reported period 2025-2
  • Phenylephrine Hydrochloride · 400 ug/10 mL · injection · reported period 2025-2
  • Phenylephrine Hydrochloride · 20 mg/250 mL · injection, solution · reported period 2025-2
  • Rocuronium Bromide · 50 mg/5 mL · injection · reported period 2025-2

Source: FDA outsourcing facility product reports (FD&C 503B(b)(2)). Retrospective by design: a row means the facility reported compounding this product to FDA in the named period, never that it currently compounds, can supply, or is endorsed for it. Public-record posture, not a determination.

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Documented public status from FDA sources. Not an approval, ranking, or endorsement. Veritura does not rank facilities. Dates below show when FDA's list was current and when we captured it, not a Veritura verification of any facility.