Form 483

Infinity Labs SD, Inc Form 483, 2023-08-21

FDA issued a Form 483 to Infinity Labs SD, Inc on 2023-08-21 with 1 public-safe observation.

483· Form 483 issuedMedical Devices & Rad Health1 observation

Infinity Labs SD, Inc · San Jose, United States · Issued August 21, 2023

Overview

  • 1 public-safe observation is 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.

21 Aug 2023
21 CFR 820.100(b)

Documentation

Cited by Kenya Destin

Inspected site

ILInfinity Labs SD, IncSan Jose, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

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

Source document

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PDF available

Form 483 source document

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Full 483 report

Get the verbatim text of all 1 observation

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