Atlas

Form 483

American Ortho-Tech (P) Ltd. Form 483, 2012-12-05

FDA issued a Form 483 to American Ortho-Tech (P) Ltd. on 2012-12-05 with 2 public-safe observations.

483· Form 483 issued2 observations

American Ortho-Tech (P) Ltd. · Chennai, Tambaram, India · Issued December 5, 2012

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.

5 Dec 2012
21 CFR 820.180

Availability

Cited by Terry C Kimball

5 Dec 2012
21 CFR 820.198(c)

Investigation of device failures

Cited by Terry C Kimball

Inspected site

AOAmerican Ortho-Tech (P) Ltd.Chennai, Tambaram, India

Inspection team

TCTerry C Kimball

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.180Cited across public-safe Form 483 observations1x
21 CFR 820.198(c)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