Form 483

Legacy Pharmaceutical Packaging, LLC Form 483, 2023-06-20

FDA issued a Form 483 to Legacy Pharmaceutical Packaging, LLC on 2023-06-20 with 4 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health4 observations

Legacy Pharmaceutical Packaging, LLC · Earth City, United States · Issued June 20, 2023

Overview

  • 4 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.

20 Jun 2023
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Edward E Lockwood

20 Jun 2023
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Edward E Lockwood

20 Jun 2023
21 CFR 820.70(i)

Software validation for automated processes

Cited by Edward E Lockwood

20 Jun 2023
21 CFR 820.70(i)

Software validation for automated processes

Cited by Edward E Lockwood

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 820.100(a)Cited across public-safe Form 483 observations2x
21 CFR 820.70(i)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 4 observations

The full inspection record, as Atlas holds it, 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