Atlas

Form 483

Nutro Laboratories, a div of NBTY, Inc. Form 483, 2010-10-29

FDA issued a Form 483 to Nutro Laboratories, a div of NBTY, Inc. on 2010-10-29 with 4 public-safe observations.

483· Form 483 issued4 observations

Nutro Laboratories, a div of NBTY, Inc. · S Plainfield, United States · Issued October 29, 2010

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

29 Oct 2010
21 CFR 111.70(b)(2)

Specifications-component purity, strength, composition

Cited by Raymond L Cheung, Dhaval H Patel

29 Oct 2010
21 CFR 111.70(c)(2)

Documentation specifications - contamination limits

Cited by Raymond L Cheung, Dhaval H Patel

29 Oct 2010
21 CFR 111.75(a)(2)(ii)(A)

Component - qualify supplier

Cited by Raymond L Cheung, Dhaval H Patel

29 Oct 2010
21 CFR 111.455(a)

Hold - temperature, humidity, light

Cited by Raymond L Cheung, Dhaval H Patel

Inspected site

NLNutro Laboratories, a div of NBTY, Inc.S Plainfield, United States

Inspection team

RLRaymond L Cheung
DHDhaval H Patel

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.455(a)Cited across public-safe Form 483 observations1x
21 CFR 111.70(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 111.70(c)(2)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 4 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