Atlas

Form 483

HydroCision, Inc. Form 483, 2014-04-16

FDA issued a Form 483 to HydroCision, Inc. on 2014-04-16 with 3 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health3 observations

HydroCision, Inc. · North Billerica, United States · Issued April 16, 2014

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

16 Apr 2014
21 CFR 803.50(a)(2)

Report of Malfunction

Cited by Jonathan B Lewis, Lisa M Ayer

16 Apr 2014
21 CFR 820.100(b)

Documentation

Cited by Jonathan B Lewis, Lisa M Ayer

16 Apr 2014
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Jonathan B Lewis, Lisa M Ayer

Inspected site

HIHydroCision, Inc.North Billerica, United States

Inspection team

JBJonathan B Lewis
LMLisa M Ayer

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.50(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 820.100(b)Cited across public-safe Form 483 observations1x
21 CFR 820.198(a)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