Form 483

Herba Natural Products, Inc Form 483, 2012-06-22

FDA issued a Form 483 to Herba Natural Products, Inc on 2012-06-22 with 8 public-safe observations.

483· Form 483 issued8 observations

Herba Natural Products, Inc · Brooklyn, United States · Issued June 22, 2012

Overview

  • 8 public-safe observations are available for this inspection.
  • 8 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.

22 Jun 2012
21 CFR 111.20(d)(1)(iv)

Physical plant - temperature, humidity controls

Cited by Meredith P Soehl

22 Jun 2012
21 CFR 111.23(b)

Records - cleaning, pest control

Cited by Meredith P Soehl

22 Jun 2012
21 CFR 111.75(c)

Specifications met - verify; finished batch

Cited by Meredith P Soehl

22 Jun 2012
21 CFR 111.103

Written procedures - quality control operations

Cited by Meredith P Soehl

22 Jun 2012
21 CFR 111.453

Written procedures - holding

Cited by Meredith P Soehl

Inspected site

HNHerba Natural Products, IncBrooklyn, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.103Cited across public-safe Form 483 observations1x
21 CFR 111.20(d)(1)(iv)Cited across public-safe Form 483 observations1x
21 CFR 111.23(b)Cited across public-safe Form 483 observations1x
21 CFR 111.453Cited across public-safe Form 483 observations1x
21 CFR 111.465(b)Cited across public-safe Form 483 observations1x
21 CFR 111.503Cited across public-safe Form 483 observations1x
21 CFR 111.553Cited across public-safe Form 483 observations1x
21 CFR 111.75(c)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 8 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