Blend.House LLC
Amended 483 issued December 21, 2022 · Reading, Pennsylvania
- Inspection
- Dec 21, 2022
- Investigators
- Alan D. Centi· Melissa M. Schafer· Tammy M. Phillips
- Observations
- 2
- Pages
- 6
- FEI number
- 3015728839
In short: On December 21, 2022, FDA issued a Amended 483 with 2 observations to Blend.House LLC in Reading, Pennsylvania (FEI 3015728839) after an inspection that ran Dec 21, 2022. The investigators were Alan D. Centi, Melissa M. Schafer and Tammy M. Phillips. The most-cited regulation is 21 CFR 106.6 (production and in-process control system).
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
You did not establish a system of process controls covering all stages of processing that was…
- 02
You did not ensure that equipment or a utensil used in the manufacture, processing, packing, or…
The full amended 483
Plus the full detail behind each one, exactly as FDA wrote it.
Get the full amended 483This inspection in context
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 firmBlend.House LLC history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar documentsOther sites cited under 106.6
See how FDA wrote the same problem up elsewhere.
Questions about this amended 483
What did FDA find at Blend.House LLC?
FDA listed 2 observations on this Form 483. The most-cited regulation is 21 CFR 106.6 (production and in-process control system). The opening words of each observation are shown on this page.
Who inspected Blend.House LLC?
Alan D. Centi, Melissa M. Schafer and Tammy M. Phillips are named on this Amended 483, for the inspection of Dec 21, 2022. Each investigator has a profile showing what they cite most.
When was Blend.House LLC inspected by FDA?
The inspection ran Dec 21, 2022, and the Amended 483 is dated December 21, 2022.
How do I get the full Amended 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.