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Form 483

LeMaitre Vascular, Inc. Form 483, 2023-04-13

FDA issued a Form 483 to LeMaitre Vascular, Inc. on 2023-04-13 with 4 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health4 observations

LeMaitre Vascular, Inc. · North Brunswick, United States · Issued April 13, 2023

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

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

13 Apr 2023
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Frank J Marciniak, Monica L Gutierrez

13 Apr 2023
21 CFR 820.30(i)

Design changes - Lack of or Inadequate Procedures

Cited by Frank J Marciniak, Monica L Gutierrez

13 Apr 2023
21 CFR 820.75(a)

Lack of or inadequate process validation

Cited by Frank J Marciniak, Monica L Gutierrez

13 Apr 2023
21 CFR 820.75(b)

Lack/Inad procedure-Monitoring/Control of Validated Proces

Cited by Frank J Marciniak, Monica L Gutierrez

Inspected site

LVLeMaitre Vascular, Inc.North Brunswick, United States

Inspection team

FJFrank J Marciniak
MLMonica L Gutierrez

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.30(i)Cited across public-safe Form 483 observations1x
21 CFR 820.75(a)Cited across public-safe Form 483 observations1x
21 CFR 820.75(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 observations

The full inspection record, as Atlas holds it, 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