Atlas

Form 483

Electromedical Products International, Inc. Form 483, 2013-02-01

FDA issued a Form 483 to Electromedical Products International, Inc. on 2013-02-01 with 3 public-safe observations.

483· Form 483 issued3 observations

Electromedical Products International, Inc. · Mineral Wells, United States · Issued February 1, 2013

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.

1 Feb 2013
21 CFR 820.30(g)

Design Validation - Risk analysis not performed/inadequate

Cited by Roy Baby

1 Feb 2013
21 CFR 820.50(a)(2)

Supplier oversight

Cited by Roy Baby

1 Feb 2013
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Roy Baby

Inspected site

EPElectromedical Products International, Inc.Mineral Wells, United States

Inspection team

RBRoy Baby

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.30(g)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