Form 483

Miami Fat Supply, Inc Form 483, 2015-10-14

FDA issued a Form 483 to Miami Fat Supply, Inc on 2015-10-14 with 18 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health18 observations

Miami Fat Supply, Inc · Fruitland Park, United States · Issued October 14, 2015

Overview

  • 18 public-safe observations are available for this inspection.
  • 9 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.

14 Oct 2015
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Richard K Vogel

14 Oct 2015
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Richard K Vogel

14 Oct 2015
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Richard K Vogel

14 Oct 2015
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Richard K Vogel

14 Oct 2015
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Richard K Vogel

Inspected site

MFMiami Fat Supply, IncFruitland Park, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.17Cited across public-safe Form 483 observations2x
21 CFR 820.100(a)Cited across public-safe Form 483 observations2x
21 CFR 820.198(a)Cited across public-safe Form 483 observations2x
21 CFR 820.22Cited across public-safe Form 483 observations2x
21 CFR 820.30(i)Cited across public-safe Form 483 observations2x
21 CFR 820.30(j)Cited across public-safe Form 483 observations2x
21 CFR 820.50Cited across public-safe Form 483 observations2x
21 CFR 820.75(a)Cited across public-safe Form 483 observations2x
21 CFR 820.80(d)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 18 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