Burpee Materials Technology, LLC

Form 483 issued March 14, 2018 · Eatontown, New Jersey

Inspection
Jan 30 – Mar 14, 2018
Investigator
Esteban Beltran
Observations
3
Pages
6
FEI number
3005089785

In short: On March 14, 2018, FDA issued a Form 483 with 3 observations to Burpee Materials Technology, LLC in Eatontown, New Jersey (FEI 3005089785) after an inspection that ran Jan 30 – Mar 14, 2018. The investigator was Esteban Beltran. Most observations concern production & process controls and cAPA.

At a glance

2 of 3 observations on this 483 concern production & process controls.

Production & process controls2
CAPA1

What FDA observed

Preview: the opening words of each observation
  1. 01

    Procedures for corrective and preventive action have…

  2. 02

    Process control procedures that describe any process controls necessary to ensure conformance to specifications have…

  3. 03

    Sampling plans are not based…

The full 483

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This inspection in context

Questions about this 483

What did FDA find at Burpee Materials Technology, LLC?

FDA listed 3 observations on this Form 483, mostly about production & process controls and cAPA. The opening words of each observation are shown on this page.

Who inspected Burpee Materials Technology, LLC?

Esteban Beltran is named on this Form 483, for the inspection of Jan 30 – Mar 14, 2018. Each investigator has a profile showing what they cite most.

When was Burpee Materials Technology, LLC inspected by FDA?

The inspection ran Jan 30 – Mar 14, 2018, and the Form 483 is dated March 14, 2018.

How do I get the full Form 483 for Burpee Materials Technology, LLC?

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