Form 483

Nutritional Counselors Of America Form 483, 2011-04-12

FDA issued a Form 483 to Nutritional Counselors Of America on 2011-04-12 with 23 public-safe observations.

483· Form 483 issued23 observations

Nutritional Counselors Of America · Spencer, United States · Issued April 12, 2011

Overview

  • 23 public-safe observations are available for this inspection.
  • 23 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.

12 Apr 2011
21 CFR 111.10(b)(1)

Outer garments

Cited by Cheryl L Watson, Kimberly Dutzek

12 Apr 2011
21 CFR 111.20(d)(1)(i)

Floors, walls, ceilings

Cited by Cheryl L Watson, Kimberly Dutzek

12 Apr 2011
21 CFR 111.20(d)(1)(iii)

Physical plant - ventilation, environmental control

Cited by Cheryl L Watson, Kimberly Dutzek

12 Apr 2011
21 CFR 111.20(d)(1)(v)

Physical plant - aisles, working spaces

Cited by Cheryl L Watson, Kimberly Dutzek

12 Apr 2011
21 CFR 111.25

Equipment - procedures

Cited by Cheryl L Watson, Kimberly Dutzek

Inspected site

NCNutritional Counselors Of AmericaSpencer, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.10(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 111.105Cited across public-safe Form 483 observations1x
21 CFR 111.135Cited across public-safe Form 483 observations1x
21 CFR 111.155(c)Cited across public-safe Form 483 observations1x
21 CFR 111.170Cited across public-safe Form 483 observations1x
21 CFR 111.180(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 111.20(d)(1)(i)Cited across public-safe Form 483 observations1x
21 CFR 111.20(d)(1)(iii)Cited across public-safe Form 483 observations1x
21 CFR 111.20(d)(1)(v)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 111.255(b)Cited across public-safe Form 483 observations1x
21 CFR 111.260(l)(1)(i)Cited across public-safe Form 483 observations1x
21 CFR 111.27(a)Cited across public-safe Form 483 observations1x
21 CFR 111.27(b)Cited across public-safe Form 483 observations1x
21 CFR 111.365(a)Cited across public-safe Form 483 observations1x
21 CFR 111.365(j)Cited across public-safe Form 483 observations1x
21 CFR 111.375(b)Cited across public-safe Form 483 observations1x
21 CFR 111.410(b)Cited across public-safe Form 483 observations1x
21 CFR 111.415(e)Cited across public-safe Form 483 observations1x
21 CFR 111.70(a)Cited across public-safe Form 483 observations1x
21 CFR 111.75(a)(2)(ii)(A)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 23 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