FDA Intel

Blend.house Al lerton, LLC

Form 483 issued February 20, 2025 · Allert on, Iowa

Inspection
Feb 11 – Feb 20, 2025
Investigators
Joselin P. Baray-Alvarado· Kawshalya Pathiraja· Lloyd M. Luapula
Observations
3
Pages
5
FEI number
1921383

In short: On February 20, 2025, FDA issued a Form 483 with 3 observations to Blend.house Al lerton, LLC in Allert on, Iowa (FEI 1921383) after an inspection that ran Feb 11 – Feb 20, 2025. The investigators were Joselin P. Baray-Alvarado, Kawshalya Pathiraja, Lloyd M. Luapula, Marc Balzarini, Ron R. Pearson and Stephen G. McLane. Most observations concern food CGMP / preventive controls.

At a glance

Observations span 1 system, led by food cgmp / preventive controls.

Food CGMP / preventive controls1
Other2

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 106.40(f)(3)

    You approved and released for use an ingredient that was not manufactured, packaged, labeled, or held…

  2. 02
    21 CFR 117.35(c)

    You did not exclude pests from your food plant to protect…

  3. 03
    21 CFR 106.20(a)

    You did not maintain a building used in the manufacture, processing, packing or holding of infant…

The full 483

Plus the full detail behind each one, exactly as FDA wrote it.

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This inspection in context

The investigator

Joselin P. Baray-Alvarado

1 document · 2025

Cites 106.20(a) (controls to prevent adulteration caused by facilities) more than any other section. Most of their documents are for sites in Iowa.

The firm

Blend.house Al lerton, LLC history

All 6 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 117.35(c)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Blend.house Al lerton, LLC?

FDA listed 3 observations on this Form 483, mostly about food CGMP / preventive controls. The opening words of each observation are shown on this page.

Who inspected Blend.house Al lerton, LLC?

Joselin P. Baray-Alvarado, Kawshalya Pathiraja, Lloyd M. Luapula, Marc Balzarini, Ron R. Pearson and Stephen G. McLane are named on this Form 483, for the inspection of Feb 11 – Feb 20, 2025. Each investigator has a profile showing what they cite most.

When was Blend.house Al lerton, LLC inspected by FDA?

The inspection ran Feb 11 – Feb 20, 2025, and the Form 483 is dated February 20, 2025.

How do I get the full Form 483 for Blend.house Al lerton, LLC?

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