Atlas

Form 483

Teco Diagnostics, Inc. Form 483, 2018-05-09

FDA issued a Form 483 to Teco Diagnostics, Inc. on 2018-05-09 with 3 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health3 observations

Teco Diagnostics, Inc. · Anaheim, United States · Issued May 9, 2018

Overview

  • 3 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.

9 May 2018
21 CFR 803.17(a)(3)

Lack of System for Timely Submission of Reports

Cited by Sonya L Karsik

9 May 2018
21 CFR 803.17(b)(1)

Info evaluated to determine if event was reportable

Cited by Sonya L Karsik

9 May 2018
21 CFR 820.50(a)(2)

Supplier oversight

Cited by Sonya L Karsik

Inspected site

TDTeco Diagnostics, Inc.Anaheim, United States

Inspection team

SLSonya L Karsik

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.17(a)(3)Cited across public-safe Form 483 observations1x
21 CFR 803.17(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 820.50(a)(2)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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