Form 483

Burpee Materials Technology LLC Form 483, 2023-08-08

FDA issued a Form 483 to Burpee Materials Technology LLC on 2023-08-08 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Burpee Materials Technology LLC · Eatontown, United States · Issued August 8, 2023

Overview

  • 2 public-safe observations are available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

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

8 Aug 2023
21 CFR 820.100(b)

Documentation

Cited by William R Chang

8 Aug 2023
21 CFR 820.100(b)

Documentation

Cited by William R Chang

Inspected site

BMBurpee Materials Technology LLCEatontown, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(b)Cited across public-safe Form 483 observations2x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Full 483 report

Get the verbatim text of all 2 observations

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