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Form 483

Tarmac Products, Inc. Form 483, 2019-09-27

FDA issued a Form 483 to Tarmac Products, Inc. on 2019-09-27 with 69 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health69 observations

Tarmac Products, Inc. · Miami Gardens, United States · Issued September 27, 2019

Overview

  • 69 public-safe observations are available for this inspection.
  • 17 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.

27 Sep 2019
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Karen M Rodriguez, Jennifer L Huntington

27 Sep 2019
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Karen M Rodriguez, Jennifer L Huntington

27 Sep 2019
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Karen M Rodriguez, Jennifer L Huntington

27 Sep 2019
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Karen M Rodriguez, Jennifer L Huntington

27 Sep 2019
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Karen M Rodriguez, Jennifer L Huntington

Inspected site

TPTarmac Products, Inc.Miami Gardens, United States

Inspection team

KMKaren M Rodriguez
JLJennifer L Huntington

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations6x
21 CFR 820.198(a)Cited across public-safe Form 483 observations6x
21 CFR 820.20(b)Cited across public-safe Form 483 observations6x
21 CFR 820.22Cited across public-safe Form 483 observations6x
21 CFR 820.30(a)Cited across public-safe Form 483 observations6x
21 CFR 820.75(a)Cited across public-safe Form 483 observations6x
21 CFR 211.160(b)Cited across public-safe Form 483 observations3x
21 CFR 211.166(a)Cited across public-safe Form 483 observations3x
21 CFR 211.192Cited across public-safe Form 483 observations3x
21 CFR 211.194(a)Cited across public-safe Form 483 observations3x
21 CFR 211.198(a)Cited across public-safe Form 483 observations3x
21 CFR 211.22(d)Cited across public-safe Form 483 observations3x
21 CFR 211.63Cited across public-safe Form 483 observations3x
21 CFR 803.17Cited across public-safe Form 483 observations3x
21 CFR 820.100(a)Cited across public-safe Form 483 observations3x
21 CFR 820.50Cited across public-safe Form 483 observations3x
21 CFR 820.72(a)Cited across public-safe Form 483 observations3x

Source document

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Form 483 source document

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Full 483 report

Get the verbatim text of all 69 observations

The source PDF, 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