Atlas

Form 483

M.d. Science Lab, L.l.c. Form 483, 2019-01-31

FDA issued a Form 483 to M.d. Science Lab, L.l.c. on 2019-01-31 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

M.d. Science Lab, L.l.c. · Deerfield Beach, United States · Issued January 31, 2019

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.

31 Jan 2019
FDCA 761(b)(1)

No AE report made (dietary supplement)

Cited by Marc Balzarini

31 Jan 2019
21 CFR 111.123(a)(1)

QC operations - master manufacturing record, modifications

Cited by Marc Balzarini

Inspected site

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

Inspection team

MBMarc Balzarini

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.123(a)(1)Cited across public-safe Form 483 observations1x
FDCA 761(b)(1)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