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Form 483

USpharma Ltd Form 483, 2023-05-11

FDA issued a Form 483 to USpharma Ltd on 2023-05-11 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

USpharma Ltd · Miami Lakes, United States · Issued May 11, 2023

Overview

  • 2 public-safe observations are available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

11 May 2023
21 CFR 803.50(a)(1)

Report of Death or Serious Injury

Cited by Ronald Ifraimov

11 May 2023
21 CFR 803.50(a)(1)

Report of Death or Serious Injury

Cited by Ronald Ifraimov

Inspected site

ULUSpharma LtdMiami Lakes, United States

Inspection team

RIRonald Ifraimov

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.50(a)(1)Cited across public-safe Form 483 observations2x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

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Full 483 report

Get the verbatim text of all 2 observations

The source PDF, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere