Atlas

Form 483

Stat Medical Devices, Inc. Form 483, 2016-05-20

FDA issued a Form 483 to Stat Medical Devices, Inc. on 2016-05-20 with 6 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health6 observations

Stat Medical Devices, Inc. · North Miami Beach, United States · Issued May 20, 2016

Overview

  • 6 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.

20 May 2016
21 CFR 803.50(a)(2)

Report of Malfunction

Cited by Karen M Rodriguez

20 May 2016
21 CFR 803.50(a)(2)

Report of Malfunction

Cited by Karen M Rodriguez

20 May 2016
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Karen M Rodriguez

20 May 2016
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Karen M Rodriguez

20 May 2016
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Karen M Rodriguez

Inspected site

SMStat Medical Devices, Inc.North Miami Beach, United States

Inspection team

KMKaren M Rodriguez

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.50(a)(2)Cited across public-safe Form 483 observations2x
21 CFR 820.100(a)Cited across public-safe Form 483 observations2x
21 CFR 820.198(a)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 6 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