Atlas

Form 483

Eckhart Corporation Form 483, 2016-08-18

FDA issued a Form 483 to Eckhart Corporation on 2016-08-18 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Eckhart Corporation · Novato, United States · Issued August 18, 2016

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

18 Aug 2016
21 CFR 111.123(a)(8)

Quality control - finished batch, distribution

Cited by Rumany C Penn

18 Aug 2016
21 CFR 111.70(e)

Specifications - identity, purity, strength, composition

Cited by Rumany C Penn

18 Aug 2016
21 CFR 111.75(a)(2)(ii)(A)

Component - qualify supplier

Cited by Rumany C Penn

Inspected site

ECEckhart CorporationNovato, United States

Inspection team

RCRumany C Penn

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.123(a)(8)Cited across public-safe Form 483 observations1x
21 CFR 111.70(e)Cited across public-safe Form 483 observations1x
21 CFR 111.75(a)(2)(ii)(A)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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