Atlas

Form 483

Xintec Corp Form 483, 2014-03-14

FDA issued a Form 483 to Xintec Corp on 2014-03-14 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Xintec Corp · Alameda, United States · Issued March 14, 2014

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

14 Mar 2014
21 CFR 820.198(c)

Investigation of device failures

Cited by Samuel K Gibbons

14 Mar 2014
21 CFR 820.198(d)

Records of MDR Investigation

Cited by Samuel K Gibbons

Inspected site

XCXintec CorpAlameda, United States

Inspection team

SKSamuel K Gibbons

Cited regulations

CFR citations associated with this Form 483.

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

Full 483 report

Get the verbatim text of all 2 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