Form 483

LD Technology, LLC Form 483, 2010-06-29

FDA issued a Form 483 to LD Technology, LLC on 2010-06-29 with 4 public-safe observations.

483· Form 483 issued4 observations

LD Technology, LLC · Miami, United States · Issued June 29, 2010

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

29 Jun 2010
21 CFR 820.22

Quality Audits - defined intervals

Cited by Richard K Vogel

29 Jun 2010
21 CFR 820.30(c)

Design input - documentation

Cited by Richard K Vogel

29 Jun 2010
21 CFR 820.30(g)

Design validation - user needs and intended uses

Cited by Richard K Vogel

29 Jun 2010
21 CFR 820.50(a)

Evaluation of suppliers, contractors, etc., requirements

Cited by Richard K Vogel

Inspected site

LTLD Technology, LLCMiami, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.22Cited across public-safe Form 483 observations1x
21 CFR 820.30(c)Cited across public-safe Form 483 observations1x
21 CFR 820.30(g)Cited across public-safe Form 483 observations1x
21 CFR 820.50(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 observations

Every observation in full, 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