Atlas

Form 483

Hain Celestial Group Form 483, 2010-04-14

FDA issued a Form 483 to Hain Celestial Group on 2010-04-14 with 26 public-safe observations.

483· Form 483 issued26 observations

Hain Celestial Group · Boulder, United States · Issued April 14, 2010

Overview

  • 26 public-safe observations are available for this inspection.
  • 24 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.

14 Apr 2010
21 CFR 111.10(b)(3)

Hand washing

Cited by Larisa E Pavlick

14 Apr 2010
21 CFR 111.10(b)(4)

Hand jewelry - remove

Cited by Larisa E Pavlick

14 Apr 2010
21 CFR 111.10(b)(5)

Gloves

Cited by Larisa E Pavlick

14 Apr 2010
21 CFR 111.10(b)(6)

Hair restraints

Cited by Larisa E Pavlick

14 Apr 2010
21 CFR 111.12

Personnel - quality control personnel - qualified

Cited by Larisa E Pavlick

Inspected site

HCHain Celestial GroupBoulder, United States

Inspection team

LELarisa E Pavlick

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.73Cited across public-safe Form 483 observations3x
21 CFR 111.10(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 111.10(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 111.10(b)(5)Cited across public-safe Form 483 observations1x
21 CFR 111.10(b)(6)Cited across public-safe Form 483 observations1x
21 CFR 111.12Cited across public-safe Form 483 observations1x
21 CFR 111.15(i)Cited across public-safe Form 483 observations1x
21 CFR 111.15(k)Cited across public-safe Form 483 observations1x
21 CFR 111.16Cited across public-safe Form 483 observations1x
21 CFR 111.160(c)(3)Cited across public-safe Form 483 observations1x
21 CFR 111.20(b)Cited across public-safe Form 483 observations1x
21 CFR 111.205(a)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 111.30(c)Cited across public-safe Form 483 observations1x
21 CFR 111.315Cited across public-safe Form 483 observations1x
21 CFR 111.315(b)Cited across public-safe Form 483 observations1x
21 CFR 111.315(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 111.320(a)Cited across public-safe Form 483 observations1x
21 CFR 111.325(b)(2)(ii)Cited across public-safe Form 483 observations1x
21 CFR 111.410(b)Cited across public-safe Form 483 observations1x
21 CFR 111.525(b)Cited across public-safe Form 483 observations1x
21 CFR 111.560(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 111.70(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 26 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