Atlas

Form 483

Ocular Therapeutix, Inc. Form 483, 2012-04-06

FDA issued a Form 483 to Ocular Therapeutix, Inc. on 2012-04-06 with 1 public-safe observation.

483· Form 483 issued1 observation

Ocular Therapeutix, Inc. · Bedford, United States · Issued April 6, 2012

Overview

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

Inspectional observations

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

6 Apr 2012
21 CFR 820.150

Lack of or inadequate procedures for storage.

Cited by Stephen C Smith, Matthew D Silverman

Inspected site

OTOcular Therapeutix, Inc.Bedford, United States

Inspection team

SCStephen C Smith
MDMatthew D Silverman

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.150Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

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