Form 483

Maryland Packaging Ltd Form 483, 2023-08-02

FDA issued a Form 483 to Maryland Packaging Ltd on 2023-08-02 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Maryland Packaging Ltd · Halethorpe, United States · Issued August 2, 2023

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

2 Aug 2023
21 CFR 114.80(a)(1)

Scheduled process

Cited by Mohamad A Chahine

2 Aug 2023
21 CFR 117.130(a)(1)

Hazard analysis - Identification of hazard

Cited by Mohamad A Chahine

2 Aug 2023
21 CFR 117.135(c)(1)

Process preventive controls - Appropriate (Adequate)

Cited by Mohamad A Chahine

Inspected site

MPMaryland Packaging LtdHalethorpe, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 114.80(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 117.130(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 117.135(c)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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