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Form 483

Xintec Corp Form 483, 2024-02-06

FDA issued a Form 483 to Xintec Corp on 2024-02-06 with 1 public-safe observation.

483· Form 483 issuedMedical Devices & Rad Health1 observation

Xintec Corp · Alameda, United States · Issued February 6, 2024

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.

6 Feb 2024
21 CFR 820.198(c)

Investigation of device failures

Cited by Maida Henesian

Inspected site

XCXintec CorpAlameda, United States

Inspection team

MHMaida Henesian

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.198(c)Cited across public-safe Form 483 observations1x

Source document

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Form 483 source document

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Full 483 report

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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