Avella of Deer Valley, Inc.
Form 483 issued July 20, 2015 · Phoenix, Arizona
- Inspection
- Jul 20, 2015
- Investigator
- Sangeeta M. Khurana
- Observations
- 3
- Pages
- 2
- FEI number
- 3006345305
In short: On July 20, 2015, FDA issued a Form 483 with 3 observations to Avella of Deer Valley, Inc. in Phoenix, Arizona (FEI 3006345305) after an inspection that ran Jul 20, 2015. The investigator was Sangeeta M. Khurana. Most observations concern facilities & equipment and packaging & labeling; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.42(c)(10)(iv) (1×) · 211.42(c)(10)(vi) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system…
- 02
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
- 03
Observation 3: scanned text, readable in the full document.
This inspection in context
Sangeeta M. Khurana
20 documents · 2014–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmAvella of Deer Valley, Inc. history
All 8 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42(c)(10)(iv)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Avella of Deer Valley, Inc.?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and packaging & labeling. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Avella of Deer Valley, Inc.?
Sangeeta M. Khurana is named on this Form 483, for the inspection of Jul 20, 2015. Each investigator has a profile showing what they cite most.
When was Avella of Deer Valley, Inc. inspected by FDA?
The inspection ran Jul 20, 2015, and the Form 483 is dated July 20, 2015.
How do I get the full Form 483 for Avella of Deer Valley, Inc.?
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.