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Form 483

Lenstec, Inc. Form 483, 2017-11-01

FDA issued a Form 483 to Lenstec, Inc. on 2017-11-01 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Lenstec, Inc. · St Petersburg, United States · Issued November 1, 2017

Overview

  • 2 public-safe observations are available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

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

1 Nov 2017
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Joshua J Silvestri

1 Nov 2017
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Joshua J Silvestri

Inspected site

LILenstec, Inc.St Petersburg, United States

Inspection team

JJJoshua J Silvestri

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.17Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 2 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