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Form 483

Lasetech LLC Form 483, 2022-02-10

FDA issued a Form 483 to Lasetech LLC on 2022-02-10 with 12 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health12 observations

Lasetech LLC · Lawrenceville, United States · Issued February 10, 2022

Overview

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

Inspectional observations

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

10 Feb 2022
21 CFR 820.184

DHR content

Cited by William R Chang

10 Feb 2022
21 CFR 820.184

DHR content

Cited by William R Chang

10 Feb 2022
21 CFR 820.25(b)

Training - Lack of or inadequate procedures

Cited by William R Chang

10 Feb 2022
21 CFR 820.25(b)

Training - Lack of or inadequate procedures

Cited by William R Chang

10 Feb 2022
21 CFR 820.30(f)

Design verification - documentation

Cited by William R Chang

Inspected site

LLLasetech LLCLawrenceville, United States

Inspection team

WRWilliam R Chang

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.184Cited across public-safe Form 483 observations4x
21 CFR 820.25(b)Cited across public-safe Form 483 observations4x
21 CFR 820.30(f)Cited across public-safe Form 483 observations4x

Source document

PDF
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Form 483 source document

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Full 483 report

Get the verbatim text of all 12 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