Arminak Solutions LLC
Form 483 issued November 3, 2023 · Corona, California
- Inspection
- Oct 30 – Nov 3, 2023
- Investigator
- Rowena S. Nguyen
- Observations
- 6
- Pages
- 4
- FEI number
- 3015196287
In short: On November 3, 2023, FDA issued a Form 483 with 6 observations to Arminak Solutions LLC in Corona, California (FEI 3015196287) after an inspection that ran Oct 30 – Nov 3, 2023. The investigator was Rowena S. Nguyen. Most observations concern facilities & equipment and production.
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 02
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent malfunctions and…
- 03
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
- 04
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Rowena S. Nguyen
12 documents · 2022–2026
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in California.
The firmArminak Solutions LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Arminak Solutions LLC?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, production and materials. The opening words of each observation are shown on this page.
Who inspected Arminak Solutions LLC?
Rowena S. Nguyen is named on this Form 483, for the inspection of Oct 30 – Nov 3, 2023. Each investigator has a profile showing what they cite most.
When was Arminak Solutions LLC inspected by FDA?
The inspection ran Oct 30 – Nov 3, 2023, and the Form 483 is dated November 3, 2023.
How do I get the full Form 483 for Arminak Solutions 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.