Atlas

Form 483

SmartScience Laboratories, Inc. Form 483, 2013-12-06

FDA issued a Form 483 to SmartScience Laboratories, Inc. on 2013-12-06 with 5 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health5 observations

SmartScience Laboratories, Inc. · Tampa, United States · Issued December 6, 2013

Overview

  • 5 public-safe observations are available for this inspection.
  • 3 structured CFR citations are 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 Dec 2013
21 CFR 211.84(d)(2)

Component identification test

Cited by Melanie W Pishnery, Nicole E Knowlton

6 Dec 2013
21 CFR 211.166(a)

Lack of written stability program

Cited by Melanie W Pishnery, Nicole E Knowlton

6 Dec 2013
21 CFR 211.166(a)

Written program not followed

Cited by Melanie W Pishnery, Nicole E Knowlton

6 Dec 2013
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Melanie W Pishnery, Nicole E Knowlton

6 Dec 2013
21 CFR 211.192

Written record of investigation incomplete

Cited by Melanie W Pishnery, Nicole E Knowlton

Inspected site

SLSmartScience Laboratories, Inc.Tampa, United States

Inspection team

MWMelanie W Pishnery
NENicole E Knowlton

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.166(a)Cited across public-safe Form 483 observations2x
21 CFR 211.192Cited across public-safe Form 483 observations2x
21 CFR 211.84(d)(2)Cited 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