Atlas

Form 483

Burpee Materials Technology LLC Form 483, 2018-12-12

FDA issued a Form 483 to Burpee Materials Technology LLC on 2018-12-12 with 6 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health6 observations

Burpee Materials Technology LLC · Eatontown, United States · Issued December 12, 2018

Overview

  • 6 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.

12 Dec 2018
21 CFR 820.70(c)

Environmental control Lack of or inadequate procedures

Cited by Li Li

12 Dec 2018
21 CFR 820.75(a)

Lack of or inadequate process validation

Cited by Li Li

12 Dec 2018
21 CFR 820.70(c)

Environmental control Lack of or inadequate procedures

Cited by Li Li

12 Dec 2018
21 CFR 820.75(a)

Lack of or inadequate process validation

Cited by Li Li

12 Dec 2018
21 CFR 820.75(b)

Lack/Inad procedure-Monitoring/Control of Validated Proces

Cited by Li Li

Inspected site

BMBurpee Materials Technology LLCEatontown, United States

Inspection team

LLLi Li

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.70(c)Cited across public-safe Form 483 observations2x
21 CFR 820.75(a)Cited across public-safe Form 483 observations2x
21 CFR 820.75(b)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 6 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