Form 483

M.d. Science Lab, L.l.c. Form 483, 2013-10-03

FDA issued a Form 483 to M.d. Science Lab, L.l.c. on 2013-10-03 with 14 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health14 observations

M.d. Science Lab, L.l.c. · Deerfield Beach, United States · Issued October 3, 2013

Overview

  • 14 public-safe observations are available for this inspection.
  • 13 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.

3 Oct 2013
21 CFR 111.70(d)

Specifications - labels, packaging

Cited by Tamara J Henderson

3 Oct 2013
21 CFR 111.70(f)

Specifications - product received for packaging, labeling

Cited by Tamara J Henderson

3 Oct 2013
21 CFR 111.70(g)

Specifications - finished packaging, labeling

Cited by Tamara J Henderson

3 Oct 2013
21 CFR 111.103

Written procedures - quality control operations

Cited by Tamara J Henderson

3 Oct 2013
21 CFR 111.403

Written procedures - labeling operations

Cited by Tamara J Henderson

Inspected site

MSM.d. Science Lab, L.l.c.Deerfield Beach, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.403Cited across public-safe Form 483 observations2x
21 CFR 111.103Cited across public-safe Form 483 observations1x
21 CFR 111.453Cited across public-safe Form 483 observations1x
21 CFR 111.70(d)Cited across public-safe Form 483 observations1x
21 CFR 111.70(f)Cited across public-safe Form 483 observations1x
21 CFR 111.70(g)Cited across public-safe Form 483 observations1x
21 CFR 211.142Cited across public-safe Form 483 observations1x
21 CFR 211.198(a)Cited across public-safe Form 483 observations1x
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.20(e)Cited across public-safe Form 483 observations1x
21 CFR 820.50Cited across public-safe Form 483 observations1x
21 CFR 820.75(a)Cited across public-safe Form 483 observations1x
21 CFR 820.80(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 14 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