Form 483

Nice-Pak Products LLC Form 483, 2022-11-07

FDA issued a Form 483 to Nice-Pak Products LLC on 2022-11-07 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Nice-Pak Products LLC · Smyrna, United States · Issued November 7, 2022

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 3 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

7 Nov 2022
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Demario L Walls, Clinton J Lott, Regan T Harp

Inspected site

NPNice-Pak Products LLCSmyrna, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x

Source document

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Form 483 source document

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Full 483 report

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The source PDF, 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