Atlas

Form 483

Cayenne Company, Inc Form 483, 2011-06-22

FDA issued a Form 483 to Cayenne Company, Inc on 2011-06-22 with 14 public-safe observations.

483· Form 483 issued14 observations

Cayenne Company, Inc · Minneapolis, United States · Issued June 22, 2011

Overview

  • 14 public-safe observations are available for this inspection.
  • 14 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.

22 Jun 2011
21 CFR 111.25

Equipment - procedures

Cited by Ivan E Reyes, Gregory W Smith

22 Jun 2011
21 CFR 111.25(c)

Procedures - equipment - cleaning, sanitizing

Cited by Ivan E Reyes, Gregory W Smith

22 Jun 2011
21 CFR 111.27(d)

Equipment - maintain, clean, sanitize

Cited by Ivan E Reyes, Gregory W Smith

22 Jun 2011
21 CFR 111.70(e)

Specifications - identity, purity, strength, composition

Cited by Ivan E Reyes, Gregory W Smith

22 Jun 2011
21 CFR 111.75(a)(1)(i)

Component - verify identity, dietary ingredient

Cited by Ivan E Reyes, Gregory W Smith

Inspected site

CCCayenne Company, IncMinneapolis, United States

Inspection team

IEIvan E Reyes
GWGregory W Smith

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.153Cited across public-safe Form 483 observations1x
21 CFR 111.180(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 111.205(a)Cited across public-safe Form 483 observations1x
21 CFR 111.25Cited across public-safe Form 483 observations1x
21 CFR 111.25(c)Cited across public-safe Form 483 observations1x
21 CFR 111.255(b)Cited across public-safe Form 483 observations1x
21 CFR 111.27(d)Cited across public-safe Form 483 observations1x
21 CFR 111.353Cited across public-safe Form 483 observations1x
21 CFR 111.453Cited across public-safe Form 483 observations1x
21 CFR 111.503Cited across public-safe Form 483 observations1x
21 CFR 111.553Cited across public-safe Form 483 observations1x
21 CFR 111.70(e)Cited across public-safe Form 483 observations1x
21 CFR 111.75(a)(1)(i)Cited across public-safe Form 483 observations1x
21 CFR 111.83(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 14 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