Atlas

Form 483

OraLabs, Incorporated Form 483, 2011-11-23

FDA issued a Form 483 to OraLabs, Incorporated on 2011-11-23 with 2 public-safe observations.

483· Form 483 issued2 observations

OraLabs, Incorporated · Parker, United States · Issued November 23, 2011

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.

23 Nov 2011
21 CFR 211.65(a)

Equipment construction - reactive surfaces

Cited by Zachery L Miller

23 Nov 2011
21 CFR 211.180(e)(1)

Review of representative number of batches

Cited by Zachery L Miller

Inspected site

OIOraLabs, IncorporatedParker, United States

Inspection team

ZLZachery L Miller

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.180(e)(1)Cited across public-safe Form 483 observations1x
21 CFR 211.65(a)Cited across public-safe Form 483 observations1x

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