Form 483

The Maros Group, LLC Form 483, 2010-06-09

FDA issued a Form 483 to The Maros Group, LLC on 2010-06-09 with 7 public-safe observations.

483· Form 483 issued7 observations

The Maros Group, LLC · Phoenix, United States · Issued June 9, 2010

Overview

  • 7 public-safe observations are available for this inspection.
  • 7 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.

9 Jun 2010
21 CFR 108.25(c)(2)

Process filing

Cited by Bruce W Benware

9 Jun 2010
21 CFR 110.40(f)

Q.C. instrument accuracy, maintenance

Cited by Bruce W Benware

9 Jun 2010
21 CFR 110.80

Reasonable precautions

Cited by Bruce W Benware

9 Jun 2010
21 CFR 114.80(a)

Quality control procedures

Cited by Bruce W Benware

9 Jun 2010
21 CFR 114.80(a)(2)

pH testing

Cited by Bruce W Benware

Inspected site

TMThe Maros Group, LLCPhoenix, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 108.25(c)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.40(f)Cited across public-safe Form 483 observations1x
21 CFR 110.80Cited across public-safe Form 483 observations1x
21 CFR 114.100(b)Cited across public-safe Form 483 observations1x
21 CFR 114.80(a)Cited across public-safe Form 483 observations1x
21 CFR 114.80(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 114.83Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 7 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