Form 483

Forward Science Technologies LLC Form 483, 2016-11-30

FDA issued a Form 483 to Forward Science Technologies LLC on 2016-11-30 with 12 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health12 observations

Forward Science Technologies LLC · Houston, United States · Issued November 30, 2016

Overview

  • 12 public-safe observations are available for this inspection.
  • 6 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.

30 Nov 2016
21 CFR 803.17(a)(2)

Lack of System for Determining MDR Events

Cited by Jocelyn C Turner

30 Nov 2016
21 CFR 803.17(a)(2)

Lack of System for Determining MDR Events

Cited by Jocelyn C Turner

30 Nov 2016
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Jocelyn C Turner

30 Nov 2016
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Jocelyn C Turner

30 Nov 2016
21 CFR 820.30(f)

Design verification - output does not meet input requirement

Cited by Jocelyn C Turner

Inspected site

FSForward Science Technologies LLCHouston, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.17(a)(2)Cited across public-safe Form 483 observations2x
21 CFR 820.100(a)Cited across public-safe Form 483 observations2x
21 CFR 820.30(f)Cited across public-safe Form 483 observations2x
21 CFR 820.30(g)Cited across public-safe Form 483 observations2x
21 CFR 820.30(i)Cited across public-safe Form 483 observations2x
21 CFR 820.90(b)(2)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 12 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