Form 483

Tarmac Products, Inc. Form 483, 2010-06-07

FDA issued a Form 483 to Tarmac Products, Inc. on 2010-06-07 with 19 public-safe observations.

483· Form 483 issued19 observations

Tarmac Products, Inc. · Miami Gardens, United States · Issued June 7, 2010

Overview

  • 19 public-safe observations are available for this inspection.
  • 19 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.

7 Jun 2010
21 CFR 211.22(a)

Lack of quality control unit

Cited by Ileana Barreto-Pettit

7 Jun 2010
21 CFR 211.25(a)

Training , Education , Experience overall

Cited by Ileana Barreto-Pettit

7 Jun 2010
21 CFR 211.25(b)

Supervisor Training/Education/Experience

Cited by Ileana Barreto-Pettit

7 Jun 2010
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Ileana Barreto-Pettit

7 Jun 2010
21 CFR 211.122(c)

Records not kept for each shipment

Cited by Ileana Barreto-Pettit

Inspected site

TPTarmac Products, Inc.Miami Gardens, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.122(c)Cited across public-safe Form 483 observations1x
21 CFR 211.122(e)Cited across public-safe Form 483 observations1x
21 CFR 211.125(a)Cited across public-safe Form 483 observations1x
21 CFR 211.125(d)Cited across public-safe Form 483 observations1x
21 CFR 211.130Cited across public-safe Form 483 observations1x
21 CFR 211.137(a)Cited across public-safe Form 483 observations1x
21 CFR 211.137(d)Cited across public-safe Form 483 observations1x
21 CFR 211.142Cited across public-safe Form 483 observations1x
21 CFR 211.142(b)Cited across public-safe Form 483 observations1x
21 CFR 211.150Cited across public-safe Form 483 observations1x
21 CFR 211.150(b)Cited across public-safe Form 483 observations1x
21 CFR 211.165(a)Cited across public-safe Form 483 observations1x
21 CFR 211.170(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 211.180(b)Cited across public-safe Form 483 observations1x
21 CFR 211.188Cited across public-safe Form 483 observations1x
21 CFR 211.22(a)Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x
21 CFR 211.25(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 19 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