Atlas

Form 483

Ocular Therapeutix, Inc. Form 483, 2018-10-26

FDA issued a Form 483 to Ocular Therapeutix, Inc. on 2018-10-26 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

Ocular Therapeutix, Inc. · Bedford, United States · Issued October 26, 2018

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.

26 Oct 2018
21 CFR 211.110(a)

Control procedures to monitor and validate performance

Cited by Sean R Marcsisin

26 Oct 2018
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Sean R Marcsisin

26 Oct 2018
21 CFR 211.84(d)(2)

Establish reliability of supplier's C of A

Cited by Sean R Marcsisin

Inspected site

OTOcular Therapeutix, Inc.Bedford, United States

Inspection team

SRSean R Marcsisin

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.110(a)Cited across public-safe Form 483 observations1x
21 CFR 211.67(a)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(2)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 observations

The full inspection record, as Atlas holds it, 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