Form 483

Nice-Pak Products LLC Form 483, 2015-06-03

FDA issued a Form 483 to Nice-Pak Products LLC on 2015-06-03 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Nice-Pak Products LLC · Smyrna, United States · Issued June 3, 2015

Overview

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

3 Jun 2015
21 CFR 211.165(a)

Testing and release for distribution

Cited by Laura L Staples, June P Page

3 Jun 2015
21 CFR 211.166(a)(3)

Valid stability test methods

Cited by Laura L Staples, June P Page

Inspected site

NPNice-Pak Products LLCSmyrna, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.165(a)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)(3)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