Atlas

Form 483

Human Design Medical, LLC Form 483, 2015-11-25

FDA issued a Form 483 to Human Design Medical, LLC on 2015-11-25 with 3 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health3 observations

Human Design Medical, LLC · North Billerica, United States · Issued November 25, 2015

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.

25 Nov 2015
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Joey C West

25 Nov 2015
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Joey C West

25 Nov 2015
21 CFR 820.50

Purchasing controls, Lack of or inadequate procedures

Cited by Joey C West

Inspected site

HDHuman Design Medical, LLCNorth Billerica, United States

Inspection team

JCJoey C West

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 820.198(a)Cited across public-safe Form 483 observations1x
21 CFR 820.50Cited 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