Atlas

Form 483

Microvention, Inc. Form 483, 2015-01-28

FDA issued a Form 483 to Microvention, Inc. on 2015-01-28 with 3 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health3 observations

Microvention, Inc. · Aliso Viejo, United States · Issued January 28, 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.

28 Jan 2015
21 CFR 803.50(a)(2)

Report of Malfunction

Cited by Stephen R Souza

28 Jan 2015
21 CFR 820.70(c)

Environmental control Lack of or inadequate procedures

Cited by Stephen R Souza

28 Jan 2015
21 CFR 820.90(a)

Nonconforming product, Lack of or inadequate procedures

Cited by Stephen R Souza

Inspected site

MIMicrovention, Inc.Aliso Viejo, United States

Inspection team

SRStephen R Souza

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 820.70(c)Cited across public-safe Form 483 observations1x
21 CFR 820.90(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