Blend.House LLC

Form 483 issued January 19, 2024 · Reading, Pennsylvania

Inspection: Dec 11, 2023 – Jan 19, 2024
Investigators: Alan D. Centi· Elizabeth P. Mayer· Kawshalya Pathiraja
Observations: 6
Pages: 6
FEI number: 3015728839

In short: On January 19, 2024, FDA issued a Form 483 with 6 observations to Blend.House LLC in Reading, Pennsylvania (FEI 3015728839) after an inspection that ran Dec 11, 2023 – Jan 19, 2024. The investigators were Alan D. Centi, Elizabeth P. Mayer, Kawshalya Pathiraja, Kyle D. Covill and Melissa M. Schafer. Most observations concern food CGMP / preventive controls; the most-cited regulation is 21 CFR 106.20 (controls to prevent adulteration caused by facilities).

At a glance

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

Food CGMP / preventive controls1

Other5

What FDA observed

Preview: the opening words of each observation

01
21 CFR 106.30(b)
You did not ensure that all smfaces that contacted ingredients, in •process materials and infant formula…
02
21 CFR 106.20(a)
You did not maintain a building used in the manufactm·e, processing, packing or holding of infant…
03
21 CFR 117.35(c)
You did not exclude pests from yom· food plant to protect…
04
21 CFR 106.6(a)
You did not implement a system of production and iii-process controls for…

2 more observations

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

Get the full 483

This inspection in context

The investigator

Alan D. Centi

3 documents · 2016–2024

Cites 106.6 (production and in-process control system) more than any other section. Most of their documents are for sites in Pennsylvania.

The firm

Blend.House LLC history

All 5 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 106.30(b)

See how FDA wrote the same problem up elsewhere.

Original PDF$99

✓ All 6 pages, as issued to the firm
✓ Searchable text
✓ Download right after checkout, yours to keep

I agree to the Terms of Service, the licence (internal use by my organization only, no sharing or resale) and the Refund Policy, and I ask for immediate access to the download, so I lose any right to cancel once it's available.

Get it free · first document

Secure checkout · receipt for expenses

Already bought it? Find an order

Licensed for use within your organization. No sharing or resale.

Complete the picture

EIR
Inspection report for this inspectionJan 19, 2024$550

Blend.House LLC site file

All 5 documents for this site in one go: $1,571 instead of ~~$1,848~~, 15% off.

See the site history

Questions about this 483

What did FDA find at Blend.House LLC?

FDA listed 6 observations on this Form 483, mostly about food CGMP / preventive controls. The most-cited regulation is 21 CFR 106.20 (controls to prevent adulteration caused by facilities). The opening words of each observation are shown on this page.

Who inspected Blend.House LLC?

Alan D. Centi, Elizabeth P. Mayer, Kawshalya Pathiraja, Kyle D. Covill and Melissa M. Schafer are named on this Form 483, for the inspection of Dec 11, 2023 – Jan 19, 2024. Each investigator has a profile showing what they cite most.

When was Blend.House LLC inspected by FDA?

The inspection ran Dec 11, 2023 – Jan 19, 2024, and the Form 483 is dated January 19, 2024.

How do I get the full Form 483 for Blend.House 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.