J.M. Smucker Pet, LLC
Form 483 issued January 9, 2020 · Bloomsburg, Pennsylvania
- Inspection
- Dec 16, 2019 – Jan 9, 2020
- Investigator
- Sean D. Duke
- Observations
- 3
- Pages
- 3
- FEI number
- 3004291002
In short: On January 9, 2020, FDA issued a Form 483 with 3 observations to J.M. Smucker Pet, LLC in Bloomsburg, Pennsylvania (FEI 3004291002) after an inspection that ran Dec 16, 2019 – Jan 9, 2020. The investigator was Sean D. Duke. Most observations concern food CGMP / preventive controls; the most-cited regulation is 21 CFR 507.34 (preventive controls).
At a glance
3 of 3 observations on this 483 concern food cgmp / preventive controls.
What FDA observed
Preview: the opening words of each observation- 01
You did not identify and implement preventive controls to ensure that any hazards requiring a preventive…
- 02
Your process controls did not include procedures, practices, and/or processes that ensure the control of parameters…
- 0321 CFR 507.49(a)(5)
You did not verify that your preventive control(s) are consistently implemented and effective by other activities…
This inspection in context
Sean D. Duke
3 documents · 2018–2021
Cites 507.19(a) (sanitation) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmJ.M. Smucker Pet, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 507.34(a)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at J.M. Smucker Pet, LLC?
FDA listed 3 observations on this Form 483, mostly about food CGMP / preventive controls. The most-cited regulation is 21 CFR 507.34 (preventive controls). The opening words of each observation are shown on this page.
Who inspected J.M. Smucker Pet, LLC?
Sean D. Duke is named on this Form 483, for the inspection of Dec 16, 2019 – Jan 9, 2020. Each investigator has a profile showing what they cite most.
When was J.M. Smucker Pet, LLC inspected by FDA?
The inspection ran Dec 16, 2019 – Jan 9, 2020, and the Form 483 is dated January 9, 2020.
How do I get the full Form 483 for J.M. Smucker Pet, LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.