Form 483

SmartScience Laboratories, Inc. Form 483, 2010-01-11

FDA issued a Form 483 to SmartScience Laboratories, Inc. on 2010-01-11 with 5 public-safe observations.

483· Form 483 issued5 observations

SmartScience Laboratories, Inc. · Tampa, United States · Issued January 11, 2010

Overview

  • 5 public-safe observations are available for this inspection.
  • 5 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.

11 Jan 2010
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Daveta L Bailey

11 Jan 2010
21 CFR 211.165(a)

Testing and release for distribution

Cited by Daveta L Bailey

11 Jan 2010
21 CFR 211.165(d)

Acceptance criteria for sampling & testing

Cited by Daveta L Bailey

11 Jan 2010
21 CFR 211.166(a)(3)

Valid stability test methods

Cited by Daveta L Bailey

11 Jan 2010
21 CFR 211.192

Written record of investigation incomplete

Cited by Daveta L Bailey

Inspected site

SLSmartScience Laboratories, Inc.Tampa, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.165(a)Cited across public-safe Form 483 observations1x
21 CFR 211.165(d)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)(3)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 5 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