Avella of Deer Valley, Inc.
Form 483 issued February 25, 2013 · Phoenix, Arizona
- Inspection
- Feb 19 – Feb 25, 2013
- Investigators
- Joey V. Quitania· Sonia R. Peterson
- Observations
- 7
- Pages
- 6
- FEI number
- 3006345305
In short: On February 25, 2013, FDA issued a Form 483 with 7 observations to Avella of Deer Valley, Inc. in Phoenix, Arizona (FEI 3006345305) after an inspection that ran Feb 19 – Feb 25, 2013. The investigators were Joey V. Quitania and Sonia R. Peterson. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and quality system account for 6 of 7 observations.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Protective apparel is not worn as necessary to protect…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Procedures designed to prevent microbiological contamination ofdrug products purporting to…
- 04
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile do not include…
This inspection in context
Joey V. Quitania
23 documents · 2009–2026
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 211.113(b)
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 7 observations on this Form 483, mostly about production, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Avella of Deer Valley, Inc.?
Joey V. Quitania and Sonia R. Peterson are named on this Form 483, for the inspection of Feb 19 – Feb 25, 2013. Each investigator has a profile showing what they cite most.
When was Avella of Deer Valley, Inc. inspected by FDA?
The inspection ran Feb 19 – Feb 25, 2013, and the Form 483 is dated February 25, 2013.
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.