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Form 483

Lenstec, Inc. Form 483, 2013-07-18

FDA issued a Form 483 to Lenstec, Inc. on 2013-07-18 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Lenstec, Inc. · St Petersburg, United States · Issued July 18, 2013

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

18 Jul 2013
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Leo J Lagrotte

18 Jul 2013
21 CFR 820.198(d)

Evaluation, timeliness, identification

Cited by Leo J Lagrotte

Inspected site

LILenstec, Inc.St Petersburg, United States

Inspection team

LJLeo J Lagrotte

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.198(a)Cited across public-safe Form 483 observations1x
21 CFR 820.198(d)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

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Full 483 report

Get the verbatim text of all 2 observations

The source PDF and 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