Form 483

Legacy Pharmaceutical Packaging, LLC Form 483, 2010-04-26

FDA issued a Form 483 to Legacy Pharmaceutical Packaging, LLC on 2010-04-26 with 2 public-safe observations.

483· Form 483 issued2 observations

Legacy Pharmaceutical Packaging, LLC · Earth City, United States · Issued April 26, 2010

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.

26 Apr 2010
21 CFR 211.180(e)(1)

Review of representative number of batches

Cited by Sherry G Bous

26 Apr 2010
21 CFR 211.198(a)

Procedures to be written and followed

Cited by Sherry G Bous

Inspected site

LPLegacy Pharmaceutical Packaging, LLCEarth City, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.180(e)(1)Cited across public-safe Form 483 observations1x
21 CFR 211.198(a)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