Atlas

Form 483

NBTY, Inc. Form 483, 2016-09-27

FDA issued a Form 483 to NBTY, Inc. on 2016-09-27 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

NBTY, Inc. · Boca Raton, United States · Issued September 27, 2016

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

27 Sep 2016
21 CFR 111.260(e)

Batch record - component; identity, weight

Cited by Jennifer L Huntington

27 Sep 2016
21 CFR 111.75(b)(1)

Specifications met, in-process - quality finished batch

Cited by Jennifer L Huntington

Inspected site

NINBTY, Inc.Boca Raton, United States

Inspection team

JLJennifer L Huntington

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.260(e)Cited across public-safe Form 483 observations1x
21 CFR 111.75(b)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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