Form 483

Quality Formulation Laboratories, Inc. Form 483, 2009-10-06

FDA issued a Form 483 to Quality Formulation Laboratories, Inc. on 2009-10-06 with 6 public-safe observations.

483· Form 483 issued6 observations

Quality Formulation Laboratories, Inc. · Paterson, United States · Issued October 6, 2009

Overview

  • 6 public-safe observations are available for this inspection.
  • 6 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.

6 Oct 2009
21 CFR 110.35(c)

Lack of effective pest exclusion

Cited by Valerie C Reed, Kerry A Kurdilla

6 Oct 2009
21 CFR 110.35(d)

Failure to clean - general

Cited by Valerie C Reed, Kerry A Kurdilla

6 Oct 2009
21 CFR 110.35(d)(5)

Shown to be effective

Cited by Valerie C Reed, Kerry A Kurdilla

6 Oct 2009
21 CFR 110.37(b)(3)

As source of contamination

Cited by Valerie C Reed, Kerry A Kurdilla

6 Oct 2009
21 CFR 110.80(b)(1)

Maintenance of equip., utensils, and finished food packaging

Cited by Valerie C Reed, Kerry A Kurdilla

Inspected site

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.35(c)Cited across public-safe Form 483 observations1x
21 CFR 110.35(d)Cited across public-safe Form 483 observations1x
21 CFR 110.35(d)(5)Cited across public-safe Form 483 observations1x
21 CFR 110.37(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(2)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 6 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